Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||2 Years and Over|
- - Patients with newly diagnosed DIPG by MRI; defined as patients with a pontine location and diffuse involvement of at least 2/3 of the pons are eligible without histologic diagnosis.
- - Treatment must begin at a minimum of 4 weeks after, but no later than 14 weeks after, the date of the completion of focal radiotherapy.
- - Prior Chemotherapy: Patients should be at least 30 days from last chemotherapy dose prior to start of CED infusion, with exception of antibody half-lives.
- - Prior Radiation: Patients must have completed prior treatment with standard focal radiotherapy as part of initial treatment for DIPG and had their last dose at least 4 weeks prior to and no later than 14 weeks from the first CED treatment.
- - Age ≥ 2 years of age.
- - Karnofsky ≥ 50 for patients > 16 years of age and Lansky ≥ 50 for patients 16 years of age and younger.
- - Life expectancy of greater than 12 weeks measured from the date of completion of radiotherapy.
- - Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
- - Organ Function Requirements.
- - Adequate Bone Marrow Function Defined as:Peripheral absolute neutrophil count (ANC) ≥1000/mm3 and platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) and normal coagulation defined as normal international normalized ratio (INR) or per institutional guidelines.
- - Adequate Renal Function Defined as: - Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 milliliters (mL)/min/1.73 m2 or.
- - A serum creatinine based on age/gender as follows: Age Maximum Serum Creatinine (mg/dL) Male Female 2 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4.
- - Adequate Liver Function Defined as: Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 x upper limit of normal (ULN) for age and serum glutamate pyruvate transaminase (SGPT) (ALT) less than or equal to 110 U/L.
- - Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled.
- - The effects of irinotecan liposome injection on the developing human fetus are unknown.
- - A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
- - Patients who had clinical and/or radiographic (MRI) progression of tumor following external beam radiation therapy.
- - Patients with metastatic disease, including leptomeningeal or subarachnoid disseminated disease.
- - Patients with tumor morphology or other imaging findings that predict poor coverage of the majority of the tumor including significant tumor volume outside the pons or presence of large cysts within the tumor that would prevent adequate tumor coverage by CED.
- - Patients who are receiving any other tumor-directed therapy.
- - Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded; the patients should be discussed with the study chair(s) and study neurosurgeon prior to any planned CED treatment.
- - Untreated symptomatic hydrocephalus determined by treating physician.
- - Patients should not be on enzyme-inducing anticonvulsants or other drugs that might interact with the cytochrome P450 enzyme system.
- - History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan, topotecan, gadolinium, or lipids.
- - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- - Female patients of childbearing potential must not be pregnant or breast-feeding.
- - Patients who are unable to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Sabine Mueller, MD, PhD|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Sabine Mueller, MD, PhD, MAS|
|Principal Investigator Affiliation||University of California, San Francisco|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Diffuse Intrinsic Pontine Glioma|
This study will assess the safety and tolerability of repeated administration of nal-IRI co-infused with gadoteridol given by intratumoral CED in children with newly diagnosed DIPG.
Experimental: Newly Diagnosed DIPG
Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI): Nal-IRI given directly into the tumor using a method called CED to newly diagnosed DIPG subjects after completion of radiotherapy. CED will be performed every 4-8 weeks. Drug concentration will start at 20mg/ml and escalate up to 40 mg/ml concentration.
Drug: - Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
Nal-IRI will be given directly into the tumor using CED.
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.
University of California, San Francisco
San Francisco, California, 94158