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Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have 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.
  • - Gliosarcoma.
  • - High-grade glioma.
  • - Anaplastic astrocytoma.
  • - Anaplastic mixed oligoastrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Anaplastic ependymoma.
  • - Must have completed radiotherapy.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - Karnofsky 60-100% Life expectancy: - More than 3 months.
Hematopoietic:
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
  • - Hemoglobin at least 10 g/dL.
Hepatic:
  • - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT/SGPT less than 3 times ULN.
  • - Alkaline phosphatase less than 2 times ULN.
Renal:
  • - BUN less than 1.5 times ULN.
  • - Creatinine less than 1.5 times ULN.
Pulmonary:
  • - Pulmonary function test with diffusion greater than 50 OR.
  • - Clearance by the pulmonary service.
Other:
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - HIV negative.
  • - No AIDS-related illness.
  • - No nonmalignant systemic disease that would preclude study.
  • - No acute infection requiring IV antibiotics.
  • - No psychiatric condition that would preclude study compliance.
  • - No frequent vomiting or medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction) - No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - No prior immunotherapy.
  • - No prior biologic therapy.
Chemotherapy:
  • - No prior chemotherapy.
Endocrine therapy:
  • - Not specified.
Radiotherapy:
  • - See Disease Characteristics.
  • - At least 2 weeks since prior radiotherapy.
Surgery: - Not specified

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.

 NCT00005637
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
Lead Sponsor

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

 Memorial Sloan Kettering Cancer Center
Principal Investigator

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

 Jeffrey J. Raizer, MD
Principal Investigator Affiliation Memorial Sloan Kettering 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:

  • - Determine the safety and efficacy of extended low-dose temozolomide when combined with carmustine after radiotherapy in patients with malignant glioma.
  • - Determine the maximum tolerated dose of this combination in this patient population.
  • - Determine time to progression as measured from baseline gadolinium-enhanced magnetic resonance imaging in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of temozolomide. Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up to 1 year in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.

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.

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

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