SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma
NCT ID: NCT00003720
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1998-07-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.
Detailed Description
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OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Six additional patients are treated at the MTD. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.
PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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semaxanib
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 750/mm3 without transfusion Hemoglobin at least 8.0 g/dL without transfusion Platelet count at least 50,000/mm3 without transfusion Hepatic: AST/ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.0 mg/dL (3.0 mg/dL if concurrent indinavir therapy) Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant Fertile patients must use effective contraception No known allergy to Cremophor or Cremophor based drug product No concurrent 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 carcinoma of the skin Carcinoma in situ of the cervix No other acute or chronic medical or psychiatric condition
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy for AIDS-related Kaposi's sarcoma At least 2 weeks since prior immunotherapy for AIDS-related Kaposi's sarcoma and recovered At least 2 weeks since prior epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) No concurrent immunotherapy Chemotherapy: At least 2 weeks since prior chemotherapy for AIDS-related Kaposi's sarcoma and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy for AIDS-related Kaposi's sarcoma No concurrent hormonal therapy (including beta-HCG) Radiotherapy: Recovered from prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No prior biopsy of measurable lesion Other: No prior laser therapy to measurable lesion Stable antiretroviral therapy for at least 2 weeks At least 3 weeks since other investigational drugs No concurrent local or topical therapy for disease No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Alison L. Hannah, MBBS
Role: STUDY_CHAIR
SUGEN
Locations
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USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
St. Francis Hospital
San Francisco, California, United States
Kaplan Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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CDR0000066829
Identifier Type: -
Identifier Source: secondary_id
LAC-USC-17K981
Identifier Type: -
Identifier Source: secondary_id
SUGEN-SU5416.003
Identifier Type: -
Identifier Source: org_study_id