SarCNU in Treating Patients With Recurrent Malignant Glioma
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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 2 |
| 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:
- Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
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
- Anaplastic astrocytoma (AA) OR
- Glioblastoma multiforme (GBM)
- Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy
At least 1 bidimensionally measurable lesion
- At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm3
- Platelet count at least 120,000/mm3
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary:
- DLCO at least 70% of predicted
- FVC at least 70% of predicted
Other:
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- No ongoing or active uncontrolled infection
- No other serious illness or medical condition that would preclude study
- No history of significant neurologic or psychiatric disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 weeks since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- At least 6 weeks since prior chemotherapy
- No more than 1 prior adjuvant chemotherapy regimen for AA
- No prior chemotherapy for recurrent disease
- No other concurrent chemotherapy
Endocrine therapy:
- Patients must be on a stable dose of steroids for at least 2 weeks prior to study
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy for recurrent disease
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed
- At least 4 weeks since prior surgery (except for biopsy)
Other:
- At least 6 weeks since prior investigational agents
- No other concurrent investigational agents
- No other concurrent anticancer treatment
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
Additional Information:
Publications:
| 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 |
Keywords provided by NCIC Clinical Trials Group:
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013