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Clinical Trial Finder

Search Results

Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma

Study Purpose

This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
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 22 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Understand and voluntarily sign and date an informed consent document before any study related assessments/procedures are conducted. 2. Males and females of age ≥18 years at the time of the signing of the informed consent document. 3. All subjects must have histologic evidence of G3 MG and radiographic evidence of recurrence or disease progression (defined as either a greater than 25% increase in the largest bi-dimensional product of enhancement, a new enhancing lesion or a significant increase in T2 FLAIR). 4. Subjects with archival tumor tissue suitable for genetic testing must give permission to access and test the tissue; subjects without archival tumor tissue are eligible. 5. No prior treatment with BEV or any anti-angiogenesis agents. 6. At least 4 weeks from surgical resection and 12 weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are 8 weeks apart. 7. All AEs resulting from prior chemotherapy, surgery or radiotherapy must have resolved to NCI-CTCAE (v. 4.03) Grade ≤1 (except for laboratory parameters outlined below). 8. Laboratory results within 7 days prior to NOVOTTF-200A administration (transfusions and/or growth factor support may be used at the discretion of the Investigator during Screening):
  • - Hemoglobin ≥9 g/dL.
  • - Absolute neutrophil count (ANC) ≥1.5 × 109/L.
  • - Platelet count ≥100 × 109/L.
  • - Serum bilirubin ≤1.5 × upper limit of normal (ULN) or ≤3 × ULN if Gilbert's disease is documented.
  • - Aspartate transaminase (AST) ≤ 2.5 ULN.
  • - Serum creatinine ≤1.5 × ULN.
9. Karnofsky Performance Status (KPS) score ≥70%. 10. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment: 1. The presence of 1p19q LOH which is diagnostic for anaplastic oligodendroglioma (AO). 2. Co-medication that may interfere with study results, e.g., immunosuppressive agents other than corticosteroids. (Steroid therapy for control of cerebral edema is allowed at the discretion of the investigator. Subjects should be on a stable dose of steroids for at least 1 week prior to study beginning.) 3. Chemotherapy administered within 4 weeks (6 weeks for an IV nitrosoureas and 12 weeks for an implanted nitrosoureas wafer) prior to Day 1 of study treatment. 4. Pregnancy or breastfeeding. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit adherence with study requirements, or disorders associated with significant immunocompromised state. 6. Known previous/current malignancy requiring treatment within ≤ 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma and superficial bladder carcinoma. 7. Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator.

Trial Details

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.

NCT03450850
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.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Daniela A. Bota
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Daniela Bota, MD
Principal Investigator Affiliation UC Irvine Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Astrocytoma, Grade III
Additional Details

Primary Objective: The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival) Secondary Objectives:

  • - To evaluate the safety of NOVOTTF-200A in the subject population.
  • - To evaluate efficacy of NOVOTTF-200A in the subject population.
  • - To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
  • - To determine if the treatment significantly modifies the patient's quality of life.
Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:
  • - FACT-Brain (FACT-Br) - FACT-Cognitive Function (FACT-Cog) Exploratory Objectives: - To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis) confers a better response to NovoTTF.
  • - To determine if the in vitro sensitivity of the glioma cells derived from patient specimens before and after the NOVOTTF-200A treatment correlates with the patient's response to treatment.

Arms & Interventions

Arms

Other: NOVOTTF-200A

NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma

Interventions

Device: - NOVOTTF-200A

NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate >= 75% (>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.

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, Irvine, Orange, California

Status

Address

University of California, Irvine

Orange, California, 92868

Nearest Location


Resources

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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