SarCNU in Treating Patients With Recurrent Malignant Glioma

• Status: Completed
• Trial end date: 2008-09-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: 2-((((2-chloroethyl)nitrosoamino)carbonyl)amino)propanamide

Criteria

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