Sarcoma, Kaposi's |
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Clinical Trial: SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma
This study has been completed.
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
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--
- Histologically proven, cutaneous AIDS-related Kaposi's sarcoma (KS); Must have failed at least 1 standard chemotherapy regimen for KS; Chemotherapy refractory (progressed during anthracycline-based or paclitaxel therapy) OR Chemotherapy intolerant (hypersensitivity to drug or unacceptable toxicity)
- HIV positive
- At least 5 measurable cutaneous lesions; No prior radiotherapy or intradermal therapy to indicator lesions OR KS-related generalized edema or edema of the extremities without evidence of active cutaneous lesions
--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
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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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