Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

• 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 I/II trial to study the effectiveness of carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI

• Glioblastoma multiforme

• Anaplastic ependymoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma OR

• Metastatic tumor to the brain other than melanoma

• Planned resection of tumor (must be first surgery for recurrent disease)

• Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3

• Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug

• Tumor is spherical, spheroid, or ovoid

• No tumors shaped into 3 or more components (e.g., multicentric or multilobulated)

• No tumors extending into the ventricular system

• Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)

• Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present

• No tumors in the following locations of the brain:

• Brainstem (pons or medulla)

• Midbrain (mesencephalon)

• Primary sensorimotor cortex in the dominant hemisphere

• Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve

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 and 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 OR

• BUN no greater than 30 mg/dL

Other:

• No active uncontrolled infection

• Afebrile (37.5 degrees C) unless fever due to tumor

• No other unstable or severe medical condition

• No complicating medical or psychiatric problem that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered

• No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No prior intracranial brachytherapy

• No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Surgery:

• See Disease Characteristics

• Prior surgery allowed

• No anti-tumor surgery within 12 weeks after study drug

Other:

• No concurrent anticoagulants

• No other concurrent investigational agents