Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00003775

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

2.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: leflunomide	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 1998

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

May 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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