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Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
Study Purpose
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 1 Year and Over |
| Gender | All |
Inclusion Criteria:
- - Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. > 2 x upper limit of normal [ULN]), at the time of initial diagnosis.
- - For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including 2 or more agents that must include an alkylating agent and a platinum-containing compound as intended to treat high-risk disease.
- - First episode of recurrent high-risk disease following completion of aggressive multi-drug frontline high-risk therapy.
- - First episode of progressive high-risk disease during aggressive multi-drug frontline therapy.
- - Primary resistant/refractory disease (less than partial response by International Neuroblastoma Response Criteria [INRC]) detected at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A3973, ANBL0532, ANBL09P1, ANBL12P1, ANBL1531, etc.).
- - Patients must have at least ONE of the following at the time of enrollment: - Measurable tumor on magnetic resonance imaging (MRI) or computed tomography (CT) scan.
- - MIBG-avid lesion detected on MIBG scan with positive uptake at a minimum of one site.
- - Patients with resistant/refractory soft tissue disease that is not MIBG avid or does not demonstrate increased FDG uptake on PET scan must undergo biopsy to document the presence of viable neuroblastoma.
- - Patients with bone marrow disease only will be eligible if they have more than 5% disease involvement (documented neuroblastoma cells) in at least one sample from bilateral bone marrow biopsies.
- - Note: Patients with elevated catecholamines (i.e. > 2 x ULN) only are NOT eligible for this study.
- - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2.
- - Primary refractory/resistant patients must have received at least 4 cycles of frontline high-risk chemotherapy.
- - At least 14 days must have elapsed since completion of myelosuppressive therapy.
- - Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent.
- - Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1.
- - No interim time prior to study entry is required following prior radiation therapy (RT) for non-target lesions.
- - Patients are eligible >= 6 weeks after autologous stem cell transplants or stem cell infusions (including stem cell infusions given as supportive care following 131 I-MIBG therapy) as long as hematologic and other eligibility criteria have been met.
- - Patients are eligible >= 6 weeks after therapeutic 131 I-MIBG provided that all other eligibility criteria are met.
- - Subjects who have previously received anti-GD2 monoclonal antibodies with or without retinoids for biologic therapy are eligible unless they have had progressive disease while receiving prior anti-GD2 therapy or progressed/relapsed within 3 months of receiving anti-GD2 therapy.
- - Subjects who have received autologous marrow infusions or autologous stem cell infusions that were purged using monoclonal antibody linked to beads are eligible.
- - Subjects who have previously received DFMO are eligible for this study provided they have not had progressive disease while receiving DFMO or progressed/relapsed within 3 months of completing DFMO.
- - Patients must not have received long-acting myeloid growth factors (e.g. pegfilgrastim) within 14 days of entry on this study.
- - For patients with solid tumors (without marrow involvement) including status post SCT: peripheral absolute neutrophil count (ANC) >= 750/uL (within 7 days prior to enrollment).
- - For patients with solid tumors (without marrow involvement) including status post SCT: platelet count >= 75,000/uL (transfusion independent) (within 7 days prior to enrollment).
- - Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and transfusion independent platelet count criteria are met (as above).
- - Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: - 1 to < 2 years (male 0.6 mg/dL, female 0.6 mg/dL) - 2 to < 6 years (male 0.8 mg/dL, female 0.8 mg/dL) - 6 to < 10 years (male 1 mg/dL, female 1 mg/dL) - 10 to < 13 years (male 1.2 mg/dL, female 1.2 mg/dL) - 13 to < 16 years (male 1.5 mg/dL, female 1.4 mg/dL) - >= 16 years (male 1.7 mg/dL, female 1.4 mg/dL) (within 7 days prior to enrollment).
- - Total bilirubin =< 1.5 x ULN for age (within 7 days prior to enrollment).
- - Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5.0 x ULN for age (=< 225 U/L).
- - Shortening fraction of >= 27% by echocardiography (ECHO) (within 7 days prior to enrollment).
- - Ejection fraction of >= 50% by ECHO or gated radionuclide study (within 7 days prior to enrollment).
- - No evidence of dyspnea at rest, no exercise intolerance, no chronic oxygen requirement, and room air pulse oximetry > 94% if there is a clinical indication for pulse oximetry.
- - Patients with a history of central nervous system (CNS) disease must have no clinical or radiological evidence of active CNS disease at the time of study enrollment.
- - Patients with seizure disorders may be enrolled if seizures are well controlled on anti-convulsants.
- - CNS toxicity =< grade 2.
Exclusion Criteria:
- - Men and women of childbearing potential and their partners must agree to use adequate contraception while enrolled on this study.
- - Patients with only elevated catecholamines (i.e. > 2 x ULN) are NOT eligible for this study.
- - Patients must have been off pharmacologic doses of systemic steroids for at least 7 days prior to enrollment.
- - Patients must not have received prior treatment with irinotecan and temozolomide.
- - Patients must not have received enzyme-inducing anticonvulsants including phenytoin, phenobarbital, or carbamazepine for at least 7 days prior to study enrollment.
- - Patients who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment are not eligible.
- - Patients must not have been diagnosed with myelodysplastic syndrome or with any malignancy other than neuroblastoma.
- - Patients with symptoms of congestive heart failure are not eligible.
- - Patients must not have >= grade 2 diarrhea.
- - Patients who are unable to tolerate oral/nasogastric/gastrostomy medications will not be eligible for this trial.
- - Patients must not have uncontrolled infection.
- - Patients with a history of grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy are not eligible.
- - Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03794349 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Margaret E Macy |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, New Zealand, Puerto Rico, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
High Risk Neuroblastoma, Recurrent Neuroblastoma, Refractory Neuroblastoma |
PRIMARY OBJECTIVE:
- I. To determine whether administration of eflornithine hydrochloride (eflornithine [DFMO]) in combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of further testing in patients with newly-diagnosed high-risk neuroblastoma.
- I. To compare progression-free survival and overall survival between patients receiving dinutuximab, irinotecan and temozolomide with and without the addition of DFMO.
- II. To define the toxicity profile of DFMO administered with dinutuximab, irinotecan and temozolomide.
- I. To characterize the immune and cytokine profiles of patients treated with DFMO/chemotherapy/dinutuximab combination and correlate with response to therapy.
- II. To evaluate GD2 levels in tumor cells from patient bone marrow samples and correlate with response to therapy.
- III. To explore whether the addition of DFMO to the dinutuximab and chemotherapy backbone affects pain as determined by patient report and opiate usage.
Arms
Active Comparator: Regimen A (chemotherapy, dinutuximab, sargramostim)
Patients receive temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12 of a 21-day cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: Regimen B (eflornithine, chemotherapy, dinutuximab)
Patients receive eflornithine PO, via NG, or G tube on days -6 to 7 and days 15-21 of cycle 1 and days 1-7 and 15-21 of subsequent cycles, temozolomide PO, via NG, or G tube on days 1-5, irinotecan hydrochloride IV over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12. Treatment duration is 28 days for cycle 1 and then every 21 days in subsequent cycles for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Biological: - Dinutuximab
Given IV
Drug: - Eflornithine Hydrochloride
Given PO or via NG or G tube
Drug: - Irinotecan Hydrochloride
Given IV
Biological: - Sargramostim
Given SC or IV
Drug: - Temozolomide
Given PO or via NG or G tube
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
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Children's Hospital of Alabama
Birmingham, Alabama, 35233
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
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Kaiser Permanente Downey Medical Center
Downey, California, 90242
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Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
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Address
Children's Hospital Los Angeles
Los Angeles, California, 90027
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Cedars Sinai Medical Center
Los Angeles, California, 90048
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Valley Children's Hospital
Madera, California, 93636
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Kaiser Permanente-Oakland
Oakland, California, 94611
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Children's Hospital of Orange County
Orange, California, 92868
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Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
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Rady Children's Hospital - San Diego
San Diego, California, 92123
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UCSF Medical Center-Mission Bay
San Francisco, California, 94158
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Children's Hospital Colorado
Aurora, Colorado, 80045
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Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
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Connecticut Children's Medical Center
Hartford, Connecticut, 06106
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Yale University
New Haven, Connecticut, 06520
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Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
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MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
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Children's National Medical Center
Washington, District of Columbia, 20010
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
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University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
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Address
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
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Address
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
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Address
Nicklaus Children's Hospital
Miami, Florida, 33155
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Address
Arnold Palmer Hospital for Children
Orlando, Florida, 32806
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Address
Nemours Children's Hospital
Orlando, Florida, 32827
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Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
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Address
Saint Mary's Medical Center
West Palm Beach, Florida, 33407
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Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, 30329
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Address
Memorial Health University Medical Center
Savannah, Georgia, 31404
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Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
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Address
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
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Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
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University of Illinois
Chicago, Illinois, 60612
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Address
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
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Address
Loyola University Medical Center
Maywood, Illinois, 60153
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Address
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
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Address
Riley Hospital for Children
Indianapolis, Indiana, 46202
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Address
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
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Address
Blank Children's Hospital
Des Moines, Iowa, 50309
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Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
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Address
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
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Norton Children's Hospital
Louisville, Kentucky, 40202
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Address
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
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Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
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Address
Eastern Maine Medical Center
Bangor, Maine, 04401
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Maine Children's Cancer Program
Scarborough, Maine, 04074
Status
Address
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
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Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
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Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
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Address
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
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Address
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
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Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
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Address
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
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Michigan State University Clinical Center
East Lansing, Michigan, 48824
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
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Address
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
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University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
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Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
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Address
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
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Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
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Address
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
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Address
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
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Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
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Address
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
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Address
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
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Address
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
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Address
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
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Address
Renown Regional Medical Center
Reno, Nevada, 89502
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Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
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Address
Morristown Medical Center
Morristown, New Jersey, 07960
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Albany Medical Center
Albany, New York, 12208
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Address
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
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Roswell Park Cancer Institute
Buffalo, New York, 14263
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Address
NYU Langone Hospital - Long Island
Mineola, New York, 11501
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The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
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University of Rochester
Rochester, New York, 14642
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State University of New York Upstate Medical University
Syracuse, New York, 13210
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Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
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Duke University Medical Center
Durham, North Carolina, 27710
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
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Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
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Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
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Cleveland Clinic Foundation
Cleveland, Ohio, 44195
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Nationwide Children's Hospital
Columbus, Ohio, 43205
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Dayton Children's Hospital
Dayton, Ohio, 45404
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Address
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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Oregon Health and Science University
Portland, Oregon, 97239
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Address
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103
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Address
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
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Rhode Island Hospital
Providence, Rhode Island, 02903
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Address
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
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BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
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East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
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Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105
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The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
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Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
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Driscoll Children's Hospital
Corpus Christi, Texas, 78411
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Medical City Dallas Hospital
Dallas, Texas, 75230
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
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Cook Children's Medical Center
Fort Worth, Texas, 76104
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Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
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Children's Hospital of San Antonio
San Antonio, Texas, 78207
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
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Primary Children's Hospital
Salt Lake City, Utah, 84113
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Address
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
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University of Virginia Cancer Center
Charlottesville, Virginia, 22908
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Address
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
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Seattle Children's Hospital
Seattle, Washington, 98105
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Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
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Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
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Madigan Army Medical Center
Tacoma, Washington, 98431
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Address
West Virginia University Healthcare
Morgantown, West Virginia, 26506
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Address
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
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John Hunter Children's Hospital
Hunter Regional Mail Centre, New South Wales, 2310
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Sydney Children's Hospital
Randwick, New South Wales, 2031
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The Children's Hospital at Westmead
Westmead, New South Wales, 2145
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Address
Queensland Children's Hospital
South Brisbane, Queensland, 4101
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Address
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006
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Address
Royal Children's Hospital
Parkville, Victoria, 3052
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Address
Perth Children's Hospital
Perth, Western Australia, 6009
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Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
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Janeway Child Health Centre
Saint John's, Newfoundland and Labrador, A1B 3V6
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Address
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
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Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
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Address
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
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Address
Children's Hospital
London, Ontario, N6A 5W9
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Address
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
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Address
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
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Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
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Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4
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Address
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, , G1V 4G2
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Address
Starship Children's Hospital
Grafton, Auckland, 1145
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Christchurch Hospital
Christchurch, , 8011
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HIMA San Pablo Oncologic Hospital
Caguas, , 00726
