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SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma - Article


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Sarcoma, Kaposi's


Clinical Trial: SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
AIDS Associated Malignancies Clinical Trials Consortium
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have AIDS -related Kaposi's sarcoma.

Condition Treatment or Intervention Phase
Quality of Life
epidemic Kaposi's sarcoma
recurrent Kaposi's sarcoma
 Drug: SU5416
Phase II

MedlinePlus related topics:  Kaposi's Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma

Further Study Details: 

Study start: January 2000

OBJECTIVES: I. Evaluate the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma.

II. Evaluate the safety and tolerability of this regimen in these patients.

III. Determine the pharmacokinetics of this regimen in these patients.

IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients.

V. Evaluate the effects of this regimen on overall quality of life and tumor specific symptoms in these patients.

PROTOCOL OUTLINE: This is a multicenter study.

Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed.

Patients are followed at 30 days after the last treatment, and every 3 months thereafter.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study within 12 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: At least 2 weeks since prior immunotherapy for AIDS-related KS and recovered; At least 2 weeks since prior biologic therapy for AIDS-related KS; No concurrent immunotherapy
  • Chemotherapy: See Disease Characteristics; At least 2 weeks since prior chemotherapy for AIDS-related KS and recovered; No other concurrent systemic chemotherapy
  • Endocrine therapy: At least 2 weeks since prior hormonal therapy for AIDS-related KS; No concurrent hormonal therapy (including beta-HCG)
  • Radiotherapy: See Disease Characteristics; At least 2 weeks since prior radiotherapy and recovered; No concurrent radiotherapy
  • Surgery: At least 4 weeks since prior surgery; No prior stereotactic surgery
  • Other: Stable antiretroviral therapy for at least 4 weeks prior to and at least 29 days during the study; Concurrent FDA approved antiretroviral agents or expanded access antiretroviral agents allowed; At least 3 weeks since other investigational agents; No concurrent local or topical therapy for AIDS-related KS; No other concurrent investigational agents

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 50-100%
  • Life expectancy: At least 3 months
  • Hematopoietic: Absolute neutrophil count at least 500/mm3; Platelet count at least 50,000/mm3
  • Hepatic: AST no greater than 5.0 times upper limit of normal; Bilirubin no greater than 2.0 mg/dL (no greater than 3.0 mg/dL if concurrent indinavir therapy)
  • Renal: Not specified
  • Cardiovascular: No myocardial infarction within the past 12 months; No severe or unstable angina; No history of unstable atherosclerotic coronary artery disease requiring coronary or peripheral artery bypass surgery within the past 2 years
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No known hypersensitivity to Cremophor or Cremophor based drug product; No uncontrolled serious infection such as: Pneumocystis carinii pneumonia; Toxoplasma brain abscess; CMV retinitis or colitis; Cryptococcal meningitis; Symptomatic Mycobacterium avium-intracellulare; No other active malignancy, except: Basal cell skin cancer; Carcinoma in situ of the cervix; No cerebral bleed; No diabetes mellitus with clinical evidence of severe peripheral vascular disease or diabetic ulcers; No other acute or chronic medical or psychiatric condition that would preclude compliance

Location Information


California
      UCLA Clinical AIDS Research and Education (CARE) Center, Los Angeles,  California,  90024,  United States

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Steven A. Miles,  Study Chair,  AIDS Associated Malignancies Clinical Trials Consortium   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067633; AMC-022
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005042
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 28, 2008



Page Updated: September 23, 2004
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