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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



Arizona Cancer Center Tucson, Arizona  85724
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
University of Colorado Cancer Center Denver, Colorado  80262
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Cancer Center of Albany Medical Center Albany, New York  12208
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Washington Medical Center Seattle, Washington  98195-6043
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Rhode Island Hospital Providence, Rhode Island  02903
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838
Henry Ford Hospital Detroit, Michigan  48202
Medical College of Wisconsin Milwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
Beckman Research Institute, City of Hope Los Angeles, California  91010
Herbert Irving Comprehensive Cancer Center New York, New York  10032
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
St. Francis Hospital San Francisco, California  94109
Medical College of Georgia Hospital and Clinics Augusta, Georgia  30912-3620
University of Iowa College of Medicine Iowa City, Iowa  52242
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224