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A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse

Phase 3
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase III Randomized Study of SU101 Versus Procarbazine for Patients With Glioblastoma Multiforme in First Relapse

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

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.

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

Inclusion 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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Alison L. Hannah, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 1998

Completion Date:

May 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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