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Temozolomide and Carmustine in Treating Patients With Anaplastic 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 drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic 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

  • - Recurrent glioblastoma - Anaplastic astrocytoma - Mixed anaplastic glioma For recurrent glioblastoma: Required documented progression must include an increase in tumor size of at least 25% or appearance of new lesion For anaplastic astrocytoma or mixed anaplastic glioma: Must have measurable, contrast enhancing disease on postoperative CT or MRI scan No postoperative radiation or chemotherapy If patients have received prior brachytherapy or stereotactic radiosurgery, they must have confirmation of true progressive disease rather than radiation necrosis by PET scanning or biopsy.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,800/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No uncontrolled arrhythmias or conduction defects No unstable or newly diagnosed angina pectoris No New York Heart Association class II-IV heart disease No congestive heart failure No major problems with edema (e.g., severe Cushing's syndrome, residual leg swelling from deep-vein thrombosis) No recent coronary artery disease No poorly controlled hypertension (diastolic greater than 110 mmHg and systolic greater than 180 mmHg) Pulmonary: DLCO greater than 80% of expected value Other: HIV negative No major psychiatric illness No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been free of disease for 5 years Not pregnant or nursing Adequate contraception required of all fertile patients.PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior nitrosourea or temozolomide No more than 1 prior chemotherapy regimen allowed for patients with glioblastoma At least 6 weeks since mitomycin or procarbazine and recovered At least 4 weeks since other prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: If receiving steroids, must be on a stable steroid dose for at least 72 hours prior to study No other concurrent endocrine therapy Radiotherapy: At least 6 weeks since radiotherapy No greater than 10-20% of marrow irradiated in prior radiotherapy No other concurrent radiotherapy Surgery: Surgery allowed

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.

NCT00003176
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
Lead Sponsor

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

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

Michael Prados, MD
Principal Investigator Affiliation UCSF Medical Center at Parnassus
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:

  • I. Evaluate the activity, measured in terms of progression free survival, of carmustine plus temozolomide in recurrent glioblastoma.
  • II. Estimate the response rate of recurrent glioblastomas to this combination.
  • III. Estimate the response rate of newly diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination.
  • IV. Evaluate the qualitative and quantitative toxicities of this combination in patients with anaplastic gliomas.
OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent glioblastoma vs.#46;anaplastic astrocytoma or mixed anaplastic glioma). Patients receive carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may continue further at the investigator's discretion. Patients with anaplastic astrocytoma or mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed periodically at the investigator's discretion, at least twice in the first 4 months, and then until death. PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic astrocytoma and mixed anaplastic glioma stratum.

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, UCLA

Los Angeles, California, 90095-1781

San Francisco, California

Status

Address

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213

Simmons Cancer Center - Dallas, Dallas, Texas

Status

Address

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154

Houston, Texas

Status

Address

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811

Madison, Wisconsin

Status

Address

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792