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


Phase 2
18 Years
N/A
Not Enrolling
Both
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
progression.

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:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Alison L. Hannah, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:

SUGEN

Authority:

United States: Food and Drug Administration

Study ID:

SUGEN-SU101.021

NCT ID:

NCT00003775

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Albert Einstein Comprehensive Cancer CenterBronx, New York  10461
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
University of Colorado Cancer CenterDenver, Colorado  80262
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Cancer Center of Albany Medical CenterAlbany, New York  12208
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Rhode Island HospitalProvidence, Rhode Island  02903
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Henry Ford HospitalDetroit, Michigan  48202
Medical College of WisconsinMilwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
University of Iowa College of MedicineIowa City, Iowa  52242
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
New York Neurological InstituteNew York, New York  10032