Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

• Status: Unknown status
• Trial end date: 1969-12-31
• 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 carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.

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

Details

• Lead Sponsor: Direct Therapeutics
• Treatments: Carmustine; Ethanol

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven supratentorial malignant glioblastoma multiforme

• Clear evidence of disease progression by MRI

• Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)

• Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm

• No brainstem (pons or medulla) or midbrain (mesencephalon) involvement

• No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve

• No tumor extension into the ventricular system

• Tumor volume no greater than 33.4 cm3

• At least one prior radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• No evidence of bleeding diathesis

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• SGOT/SGPT no greater than 2.5 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance at least 40 mL/min

• BUN no greater than 30 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active uncontrolled infection

• Afebrile unless fever due to presence of tumor

• No other concurrent serious medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy and recovered

• No prior intracranial brachytherapy

Surgery:

• Recovered from any prior surgery

Other:

• No prior anticoagulants

• No other concurrent investigational agents