NCT00003720

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

June 16, 2004

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

First QC Date

November 1, 1999

Last Update Submit

August 22, 2012

Conditions

Sarcoma

Keywords

AIDS-related Kaposi sarcomarecurrent Kaposi sarcoma

Interventions

semaxanibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

St. Francis Hospital

San Francisco, California, 94109, United States

Location

Kaplan Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

SarcomaAIDS-related Kaposi sarcomaSarcoma, Kaposi

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular Tissue

Study Officials

  • Alison L. Hannah, MBBS

    SUGEN

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 16, 2004

Study Start

July 1, 1998

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

US(4)