Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006656
• Other study ID #: CDR0000068207
• Secondary ID: DTI-9901UCMC-000
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 6, 2000
• Last updated: November 5, 2013
• Start date: June 2000

Study information

• Verified date: August 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• carmustine in ethanol

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Evanston Northwestern Health Care	Evanston	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Massey Cancer Center	Richmond	Virginia
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Direct Therapeutics

Country where clinical trial is conducted

United States,