Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00003775
First received: November 1, 1999
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: leflunomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of SU101 for Patients With Anaplastic Astrocytoma in First Relapse

Resource links provided by NLM:


Further study details as provided by Pfizer:

Enrollment: 60
Study Start Date: December 1998
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003775

  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Chair: Alison L. Hannah, MBBS SUGEN
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00003775     History of Changes
Other Study ID Numbers: SUGEN-SU101.021, CDR0000066904, MSKCC-98111, NCI-G99-1506
Study First Received: November 1, 1999
Last Updated: September 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
recurrent adult brain tumor
adult anaplastic astrocytoma
adult mixed glioma

Additional relevant MeSH terms:
Astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014