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

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

Condition	Treatment or Intervention	Phase
epidemic Kaposi's sarcoma recurrent Kaposi's sarcoma	Drug: SU5416	Phase I

Further Study Details: 

OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposi's sarcoma.

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

III. Evaluate the antitumor effects and biological activity of this regimen in these patients.

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

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy proven Kaposi's sarcoma that is stable or progressing while receiving standard therapy
• HIV positive
• No severe pulmonary Kaposi's sarcoma
• Five measurable lesions of at least 10 mm or lesions present for at least 30 days OR KS-related generalized edema or edema of the extremities without evidence of active mucocutaneous lesions

--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

--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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      St. Francis Hospital, San Francisco,  California,  94109,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States
New York
      Kaplan Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Alison L. Hannah,  Study Chair,  SUGEN   

Study ID Numbers:  CDR0000066829; SUGEN-SU5416.003; LAC-USC-17K981
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003720
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08