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Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carmustine in ethanol
conventional surgery
Sponsored by
Direct Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • UCSF Cancer Center and Cancer Research Institute
  • Stanford University Medical Center
  • University of Colorado Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Emory University Hospital - Atlanta
  • Evanston Northwestern Health Care
  • John F. Kennedy Medical Center
  • Barrett Cancer Center
  • University of Texas - MD Anderson Cancer Center
  • Massey Cancer Center
  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
November 5, 2013
Sponsor
Direct Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00006656
Brief Title
Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Official Title
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Direct Therapeutics

4. Oversight

5. Study Description

Brief 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.
Detailed 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine in ethanol
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene David Resnick, MD
Organizational Affiliation
Millennix
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9416
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
John F. Kennedy Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0631
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

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