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

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

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

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

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

Inclusion 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)

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

Type of Study:


Study Design:

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:

December 1998

Completion Date:

May 2006

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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