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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005855
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carmustine Drug: efaproxiral Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2000
Actual Study Completion Date : October 2006

Primary Outcome Measures :
  1. Safety and tolerability
  2. Maximum tolerated dose
  3. Pharmacokinetic profile
  4. Efficacy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm^3


  • 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


  • Creatinine no greater than 2.0 mg/dL


  • Resting oxygen saturation on room air at least 90% by pulse oximetry
  • FVC, DLCO, and FEV_1 at least 50% of normal


  • 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


Biologic therapy:

  • At least 3 weeks since prior investigational biologics


  • 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


  • See Disease Characteristics
  • At least 90 days since prior radiotherapy


  • Not specified


  • At least 3 weeks since other prior investigational drugs or devices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005855

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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)
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Study Chair: Pamela Z. New, MD The University of Texas Health Science Center, Houston
Layout table for additonal information Identifier: NCT00005855    
Other Study ID Numbers: CDR0000067881
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: December 2003
Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antisickling Agents