Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

September 12, 2012 updated by: Pfizer

A Phase II Open Label Study of SU101 for Patients With Anaplastic Astrocytoma in First Relapse

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 leflunomide in treating patients who have anaplastic astrocytoma in first relapse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the median time to progression, median survival, and objective response of patients with anaplastic astrocytoma or anaplastic oligoastrocytoma in first relapse treated with intravenous leflunomide (SU101). II. Assess the safety of SU101 in these patients. III. Describe the health-related quality of life of patients treated with intravenous SU101.

OUTLINE: This is an open label, multicenter study. Patients receive leflunomide (SU101) IV over 6 hours on days 1-4. Patients then receive SU101 IV over 6 hours weekly for 6 weeks (beginning between days 8-12). Patients exhibiting complete response, partial response, or stable disease may continue on treatment for up to a year or until disease progression or unacceptable toxicity occurs. Patients continuing therapy receive SU101 IV over 6 hours every week for 7 weeks, followed by 1 week of rest. Quality of life is assessed every 8 weeks and at the end of the study. Patients are followed every 8 weeks or until tumor progression.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85001-2071
        • St. Joseph's Hospital and Medical Center
    • California
      • Los Angeles, California, United States, 90033-0800
        • USC/Norris Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer Center
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa College of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0752
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • New York
      • Albany, New York, United States, 12208
        • Cancer Center of Albany Medical Center
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10032
        • New York Neurological Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Barrett Cancer Center, The University Hospital
      • Columbus, Ohio, United States, 43210
        • Arthur G. James Cancer Hospital - Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030
        • University of Texas - MD Anderson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma or anaplastic oligoastrocytoma in first relapse Recurrence or progression at least 6 months from initial diagnosis Must have received maximally feasible surgical resection and fractionated external beam radiotherapy Must have received no more than 1 prior systemic cytotoxic chemotherapy regimen for initial disease Bidimensionally measurable disease by MRI scan (stable dose of corticosteroids for at least 7 days prior to scan)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 9 g/dL Hepatic: AST no greater than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 40 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after the study No known allergy to etoposide No other acute or chronic medical illness or psychiatric disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (2 weeks since vincristine; 6 weeks since nitrosoureas or mitomycin) and recovered No prior leflunomide (SU101) therapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy (except medroxyprogesterone acetate for appetite stimulation) Radiotherapy: See Disease Characteristics No more than 1 prior course of radiotherapy At least 8 weeks since prior radiotherapy and recovered No prior interstitial radiotherapy or implanted carmustine wafers Prior radiosensitizer(s) concurrent with radiotherapy or used as neoadjuvant therapy allowed No concurrent radiotherapy Surgery: See Disease Characteristics No more than 2 prior surgical resections At least 1 week since prior surgery or biopsy for anaplastic astrocytoma No concurrent surgery (including resection, stereotactic surgery, or interstitial implants) Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

September 13, 2004

First Posted (ESTIMATE)

September 14, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUGEN-SU101.021
  • CDR0000066904
  • MSKCC-98111
  • NCI-G99-1506

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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