cropped color_logo_with_background.png

Clinical Trial Finder

Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

Study Purpose

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed malignant glioma (glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma) - Recurrent or progressive primary CNS neoplasm by contrast-enhanced MRI.
  • - Tumor progression after prior surgery, radiotherapy, or chemotherapy.
  • - Measurable or evaluable disease.
  • - Failed prior standard curative or palliative therapy (phase I only) PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - At least 3 months.
Hematopoietic.
  • - Absolute neutrophil count ≥ 2,000/mm^3.
  • - Platelet count ≥ 100,000/mm^3.
Hepatic.
  • - SGPT and SGOT ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) - Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present) - Bilirubin normal.
Renal.
  • - Creatinine ≤ 1.5 times ULN.
Cardiovascular.
  • - No myocardial infarction with the past year.
  • - No heart failure (including cardiac insufficiency controlled by digitalis and diuretics) - No irreversible arrhythmias requiring permanent medication.
  • - No uncontrolled hypertension.
Gastrointestinal.
  • - No gastrointestinal dysfunction that would alter absorption or motility, such as any of the following: - Active peptic ulcer.
  • - Inflammatory bowel disease.
  • - Known intolerance to lactose.
  • - Malabsorption syndromes.
  • - Intestinal sub-occlusion.
Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective barrier contraception.
  • - No active infection.
  • - No mentally incapacitated patients.
  • - No other concurrent severe disease that would preclude study participation.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - No concurrent immunotherapy.
Chemotherapy.
  • - See Disease Characteristics.
  • - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No more than 1 prior chemotherapy regimen.
  • - No other concurrent chemotherapy.
Endocrine therapy.
  • - Concurrent corticosteroids allowed if dose stable for the past 2 weeks.
  • - No concurrent hormonal therapy.
Radiotherapy.
  • - See Disease Characteristics.
  • - At least 4 weeks since prior radiotherapy.
  • - No concurrent radiotherapy.
Surgery.
  • - See Disease Characteristics.
  • - At least 3 weeks since prior surgical resection.
  • - No prior gastrointestinal surgery that would affect drug absorption.
Other.
  • - More than 4 weeks since prior participation in any other investigational drug study.
  • - More than 72 hours since prior systemic antibiotics.
  • - No concurrent H2 antagonists, antacids, or proton pump inhibitors.
  • - If any of these therapies are necessary, ≥ 3 hours must elapse after gimatecan administration.
  • - No other concurrent anticancer therapy.
  • - No other concurrent investigational drugs.
- No other concurrent immunosuppressive agents

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.

 NCT00087061
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 1/Phase 2
Lead Sponsor

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

 Jonsson Comprehensive Cancer Center
Principal Investigator

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

 Timothy F. Cloughesy, MD
Principal Investigator Affiliation Jonsson Comprehensive Cancer Center
Agency Class

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

 Other, NIH
Overall Status Completed
Countries United States
Conditions

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

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES: Primary.

  • - Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
  • - Determine whether this drug has sufficient activity to warrant further development in these patients.
(phase II) Secondary.
  • - Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • - Determine the pharmacokinetic behaviors of this drug in these patients.
  • - Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
  • - Determine the antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs.#46;no).
  • - Phase I: Patients receive oral gimatecan once daily on days 1-5.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gimatecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  • - Phase II: Patients receive gimatecan as in phase I at the MTD.
Patients are followed for at least 1 month and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I [15-21 per stratum] and 21-41 for phase II) will be accrued for this study within 24 months.

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.

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095

Powered By