Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Direct Therapeutics

Status and phase

Unknown

Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Procedure: conventional surgery

Drug: carmustine in ethanol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00006656

NCI-V00-1623

DTI-9901

CDR0000068207

UCMC-00042402

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
Determine the qualitative and quantitative toxicity of this regimen in these patients.
Assess the activity of this regimen in these patients.
Estimate peripheral blood carmustine levels in these patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.

Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)

Additional patients then receive treatment with DTI-015 at the recommended phase II dose.

Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.

PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: