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

Alternate Title

SU-101 Compared With Procarbazine in Treating Patients With Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	Pharmaceutical / Industry	SUGEN-SU101.015 MSKCC-98020, UCLA-HSPC-980105201, NCT00003293

Objectives

I.  Compare the median survival of patients with glioblastoma multiforme in 
first relapse treated with intravenous leflunomide (SU101) administered as a 
loading dose with weekly maintenance therapy versus oral, single-agent 
procarbazine administered daily for 28 days every 56 days.

II.  Compare the median time to progression for these regimens in these 
patients.

III.  Assess the objective response of these patients.

IV.  Assess the safety of SU101 given on this schedule.

V.  Describe the health-related quality of life of these patients.

Entry Criteria

Disease Characteristics:

Histologically proven refractory or recurrent supratentorial glioblastoma
multiforme

Bidimensionally measurable, enhancing residual disease by T1-weighted
gadolinium-enhanced MRI required within 15 days prior to treatment
 Stable dose of corticosteroids required for at least 7 days prior to scan

Prior/Concurrent Therapy:

 
Biologic therapy:
 Not specified

Chemotherapy:
 No prior leflunomide (SU101) therapy
 No more than one prior single-agent or combination systemic chemotherapy
  regimen for initial disease
 Radiosensitizer(s) concurrent with radiotherapy allowed in addition to
  chemotherapy for primary disease
 At least 6 weeks since nitrosourea or mitomycin
 At least 2 weeks since vincristine
 No prior single-agent procarbazine
 At least 4 weeks since other chemotherapy
 No concurrent chemotherapy agents

Endocrine therapy:
 No concurrent hormone therapy (except medroxyprogesterone acetate for
  appetite stimulation)
 Less than 4 weeks of prior hormonal therapy (tamoxifen or retinoids) if
  failed one prior chemotherapy regimen

Radiotherapy:
 Prior conventional radiotherapy for initial disease required
 No more than one prior course of radiotherapy
 At least 8 weeks since radiotherapy
 No prior interstitial radiotherapy
 No concurrent radiotherapy

Surgery:
 Maximally feasible resection for initial disease required
  No more than two resections permitted
 At least 1 week since surgery and/or biopsy for disease  
 No prior interstitial radiotherapy or implanted BCNU-wafers 
 No concurrent surgery (including resection, stereotactic surgery or
  interstitial implants)

Other:
 No concurrent investigational agent
 At least 4 weeks since prior investigational agent
 At least 1 week since cholestyramine or monoamine oxidase inhibitors

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 without blood transfusions for 15 days prior to
  treatment

Hepatic:
 AST/SGOT 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 allergic to etoposide
 Effective contraception required of fertile patients
 Negative serum pregnancy test required of fertile women
 No other acute or chronic medical or psychiatric condition

Expected Enrollment

A maximum of 380 patients will be accrued for this study.

Outline

This is a randomized, open label, multicenter study.  Patients are stratified 
according to performance status (Karnofsky 60-80% vs 90-100%), age (less than 
50 vs 50 and over), and time from initial diagnosis to recurrence (6 months or 
greater vs less than 6 months).

Patients are randomized to one of two treatment arms.

Arm I: Patients receive leflunomide (SU101) IV over 6 hours daily on days 1-4, 
again 4-8 days later, and weekly thereafter for a total of 4 loading dose 
infusions and six maintenance infusions in course 1.  Patients receive 7 
weekly maintenance infusions of SU101 in courses thereafter.  Treatment 
repeats every 8 weeks.

Arm II: Patients receive procarbazine orally once or twice daily for 4 weeks. 
Treatment is repeated every 8 weeks.

All patients complete a health-related quality-of-life questionnaire every 8 
weeks and at study withdrawal.

Treatment courses continue up to a maximum of 1 year in the absence of 
unacceptable toxicity or disease progression.

Patients are followed every 2 months, beginning 30 days after study completion.

Trial Contact Information

Trial Lead Organizations

SUGEN, Incorporated - Redwood City

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

Registry Information
Official Title		A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse
Trial Start Date		1998-02-17
Registered in ClinicalTrials.gov		NCT00003293
Date Submitted to PDQ		1998-04-13
Information Last Verified		2007-05-17

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