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Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carmustine
efaproxiral
Sponsored by
New Approaches to Brain Tumor Therapy Consortium
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 adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy Measurable disease by serial MRI or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: Resting oxygen saturation on room air at least 90% by pulse oximetry FVC, DLCO, and FEV_1 at least 50% of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious concurrent medical illness that would preclude study compliance No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior investigational biologics Chemotherapy: See Disease Characteristics No prior nitrosoureas for glioma No more than 1 prior chemotherapy regimen At least 4 weeks since prior chemotherapy No prior efaproxiral Endocrine therapy: Concurrent corticosteroids (e.g., dexamethasone) allowed Radiotherapy: See Disease Characteristics At least 90 days since prior radiotherapy Surgery: Not specified Other: At least 3 weeks since other prior investigational drugs or devices

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Winship Cancer Institute of Emory University
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital Cancer Center
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Wake Forest University Comprehensive Cancer Center
  • Abramson Cancer Center of the University of Pennsylvania
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Safety and tolerability
Maximum tolerated dose
Pharmacokinetic profile
Efficacy

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 20, 2013
Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005855
Brief Title
Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
Official Title
A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)

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. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma.
Detailed Description
OBJECTIVES: Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma. Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine in this patient population. Determine the pharmacokinetic profile of this regimen in these patients. Estimate the efficacy of this regimen at the MTD in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13). Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose. Patients are followed at 6 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.

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
adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
efaproxiral
Primary Outcome Measure Information:
Title
Safety and tolerability
Title
Maximum tolerated dose
Title
Pharmacokinetic profile
Title
Efficacy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy Measurable disease by serial MRI or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) SGOT and SGPT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Pulmonary: Resting oxygen saturation on room air at least 90% by pulse oximetry FVC, DLCO, and FEV_1 at least 50% of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other serious concurrent medical illness that would preclude study compliance No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior investigational biologics Chemotherapy: See Disease Characteristics No prior nitrosoureas for glioma No more than 1 prior chemotherapy regimen At least 4 weeks since prior chemotherapy No prior efaproxiral Endocrine therapy: Concurrent corticosteroids (e.g., dexamethasone) allowed Radiotherapy: See Disease Characteristics At least 90 days since prior radiotherapy Surgery: Not specified Other: At least 3 weeks since other prior investigational drugs or devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Z. New, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States

12. IPD Sharing Statement

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Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

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