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SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00004868
Recruitment Status : Completed
First Posted : May 23, 2003
Last Update Posted : June 27, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.

PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: semaxanib Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of SU5416 in patients with recurrent malignant glioma who are, as well as those who are not, taking enzyme-inducing antiepileptic drugs.
  • Determine the toxic effects (safety profile) of this drug in this patient population.
  • Characterize the pharmacokinetics of this drug in these patients.
  • Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo, including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.

Phase II:

  • Determine the efficacy of SU5416, in terms of 6-month progression-free survival, in patients with recurrent high-grade glioma.
  • Determine, further, the safety profile of the phase II dose of this drug in this patient population.
  • Develop exploratory data relative to surrogate endpoints of angiogenic activity in vivo including functional imaging and in vitro assays of endothelial cell inhibition and serum angiogenic peptides.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (no vs yes).

Patients receive SU5416 IV on days 1 and 4 weekly for 4 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD has been determined, additional patients are accrued to the phase II portion of the study. These patients receive SU5416 IV, as in the phase I portion, at the appropriate MTD established in phase I.

Patients are followed for survival.

PROJECTED ACCRUAL: At least 30 patients will be accrued for the phase I dose-escalation portion of this study within 10 months. An additional 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for the phase II portion of this study within 6-8 months.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of SU5416 in Patients With Recurrent High Grade Astrocytomas or Mixed Gliomas
Actual Study Start Date : March 24, 2000
Actual Primary Completion Date : September 15, 2004
Actual Study Completion Date : September 15, 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven supratentorial malignant primary glioma, including:

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma not otherwise specified
    • Benign or malignant meningiomas, including brain and spinal meningiomas
  • Patients with meningiomas are excluded from phase II portion of study
  • Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI
  • Must have failed prior radiotherapy
  • Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days

    • Must be on stable (unchanged) dose of steroids for at least 5 days before scans
  • Phase II:

    • Must have completed radiotherapy at least 2 months prior to enrollment



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks


  • WBC at least 2,300/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL (transfusion allowed)


  • SGOT less than 2.5 times upper limit of normal
  • Bilirubin normal
  • No significant active hepatic disease


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No significant active renal disease


  • No uncompensated coronary artery disease on ECG or physical examination
  • No history of myocardial infarction or severe/unstable angina within the past 6 months
  • No deep venous or arterial thrombosis within the past 3 months


  • No pulmonary embolism within the past 3 months


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months after study
  • No other serious concurrent illness
  • No significant active psychiatric disease
  • No diabetes mellitus with severe peripheral vascular disease
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No serious active infection
  • No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism


Biologic therapy:

  • At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered
  • No concurrent immunotherapy


  • Phase I:

    • No more than 2 prior chemotherapy regimens for recurrent disease
  • Phase II:

    • No more than 1 prior chemotherapy regimen for recurrent disease
  • At least 2 weeks since prior vincristine
  • At least 6 weeks since prior nitrosoureas
  • At least 3 weeks since prior procarbazine
  • Recovered from prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered


  • See Disease Characteristics
  • No concurrent radiotherapy


  • Recovered from prior surgery
  • Recent prior resection of recurrent or progressive tumor allowed


  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004868

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Maryland
Neuro-Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0752
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00004868    
Obsolete Identifiers: NCT00006067
Other Study ID Numbers: NABTC-9902
CDR0000067527 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: May 23, 2003    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent adult brain tumor
adult meningioma
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult grade III meningioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action