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Brain and Central Nervous System TumorsPhase 2NCT00003775

Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

A Phase 2 study testing leflunomide in people with Brain and Central Nervous System Tumors, run by Pfizer at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 leflunomide in treating patients who have anaplastic astrocytoma in first relapse. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
leflunomide
How many people
60 participants
Where
26 sitesin 2 countries
Study dates
Dec 1998to May 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States22 sites
  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • University of Iowa College of Medicine

    Iowa City, Iowa, 52242

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033-0800

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Neurological Institute

    New York, New York, 10032

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85001-2071

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

Other trials in United States

Canada4 sites
  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
leflunomide
Keywords
recurrent adult brain tumor, adult anaplastic astrocytoma, adult mixed glioma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Astrocytoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leflunomideDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2004 (estimated)
  2. Study startDec 1998
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003775
Sponsor's protocol ID
SUGEN-SU101.021
Other IDs
CDR0000066904, MSKCC-98111, NCI-G99-1506
Status last verified
Sep 2012
First submitted
1 Nov 1999
Last updated
13 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing leflunomide in people with Brain and Central Nervous System Tumors, run by Pfizer at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2012.

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