Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma - Full Text View

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: carmustine Drug: temozolomide	Phase 1


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy

Resource links provided by NLM:

Drug Information available for: Carmustine Temozolomide

Genetic and Rare Diseases Information Center resources: Glioblastoma Oligodendroglioma Glioma Anaplastic Astrocytoma Anaplastic Oligodendroglioma Gliosarcoma Ependymoma Anaplastic Ependymoma Neuroepithelioma

U.S. FDA Resources

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


Study Start Date:	December 1999
Study Completion Date:	December 2009
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005637

Locations


United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Jeffrey J. Raizer, MD	Memorial Sloan Kettering Cancer Center

More Information


ClinicalTrials.gov Identifier:	NCT00005637 History of Changes
Other Study ID Numbers:	CDR0000067793 MSKCC-99114 NCI-G00-1765
Study First Received:	May 2, 2000
Last Updated:	April 2, 2013
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):


adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma	adult giant cell glioblastoma adult gliosarcoma adult anaplastic ependymoma

Additional relevant MeSH terms:


Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial	Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Temozolomide Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 28, 2016