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Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: North American Brain Tumor Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003176
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carmustine
Drug: temozolomide
Phase II

MedlinePlus related topics:   Cancer   

Drug Information available for:   Carmustine    Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   82
Study Start Date:   January 1998

Detailed Description:

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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003176

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
UCSF Cancer Center and Cancer Research Institute    
      San Francisco, California, United States, 94115-0128
United States, Massachusetts
Dana-Farber Cancer Institute    
      Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0752
United States, Pennsylvania
Children's Hospital of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Cancer Institute    
      Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Simmons Cancer Center - Dallas    
      Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio    
      San Antonio, Texas, United States, 78284-7811
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center    
      Madison, Wisconsin, United States, 53792

Sponsors and Collaborators
North American Brain Tumor Consortium
National Cancer Institute (NCI)

Investigators
Study Chair:     Michael D. Prados, MD     UCSF Medical Center at Parnassus    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000065986, NABTC-9701, NCI-T96-0082
First Received:   November 1, 1999
Last Updated:   November 22, 2008
ClinicalTrials.gov Identifier:   NCT00003176
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor  
adult glioblastoma  
adult anaplastic astrocytoma  
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Carmustine
Central Nervous System Neoplasms
Temozolomide
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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