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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00304122 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with Kaposi's sarcoma (KS).
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: sorafenib tosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I and Pharmacokinetic Study of BAY 43-9006 (Sorafenib) in Patients With Kaposi's Sarcoma |
Estimated Enrollment: | 45 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, parallel group study . Patients are stratified according to concurrent ritonavir treatment (yes vs no) and HIV-related Kaposi's sarcoma (KS) (yes vs no).
Patients receive oral sorafenib once or twice daily on days 1-21. Treatment repeats every 21 days for up to 18 courses (54 weeks) in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After completion of study therapy, patients are followed at 3-6 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Kaposi's sarcoma (KS)
Measurable disease, as defined by 1 of the following:
Patients with HIV-related KS must be receiving and willing to comply with a highly active antiretroviral therapy (HAART) regimen that either utilizes ≥ 3 drugs OR attains suppression of HIV to below the limit of detection (50 copies HIV/mL)
HIV-related KS lesions must meet 1 of the following criteria:
PATIENT CHARACTERISTICS:
No other prior or concurrent malignant tumors, except for the following:
No other abnormality that would be scored as ≥ grade 3 toxicity, except any of the following:
No uncontrolled intercurrent illness, including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic anticoagulation
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Robert Yarchoan, MD | NCI - HIV and AIDS Malignancy Branch |
Study ID Numbers: | CDR0000467557, NCI-06-C-0083, NCI-7048, NCI-P6700 |
Study First Received: | March 15, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00304122 History of Changes |
Health Authority: | Unspecified |
classic Kaposi sarcoma AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Virus Diseases Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Malignant Mesenchymal Tumor Sarcoma, Kaposi Sarcoma |
DNA Virus Infections Protein Kinase Inhibitors Sorafenib Recurrence Kaposi Sarcoma Herpesviridae Infections |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Sarcoma, Kaposi Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue DNA Virus Infections Sorafenib |