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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Information provided by: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00036660 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: SarCNU |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma |
| Study Start Date: | August 2001 |
| Study Completion Date: | September 2008 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma
At least 1 bidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Canada, Alberta | |
| Tom Baker Cancer Center - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, Ontario | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Toronto General Hospital | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Study Chair: | Lawrence C. Panasci, MD | Jewish General Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00036660 History of Changes |
| Other Study ID Numbers: | I142, CAN-NCIC-IND142, CDR0000068652 |
| Study First Received: | May 13, 2002 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
|
Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue 2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |