Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Leflunomide in Treating Patients With Anaplastic Astrocytoma in First Relapse

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	SUGEN-SU101.021 MSKCC-98111, NCI-G99-1506, NCT00003775

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.

Entry 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)

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

SUGEN, Incorporated - South San Francisco

Alison L. Hannah, MBBS, Protocol chair		Ph: 650-553-8415 Email: alisonh@sugen.sf.ca.us

Registry Information
Official Title		A Phase II Open Label Study of SU101 for Patients with Anaplastic Astrocytoma in First Relapse
Trial Start Date		1998-12-16
Registered in ClinicalTrials.gov		NCT00003775
Date Submitted to PDQ		1999-02-11
Information Last Verified		2000-05-01

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