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| Sponsor: | AIDS Associated Malignancies Clinical Trials Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01016730 |
Purpose
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying the side effects and best dose of bortezomib in treating patients with relapsed or refractory AIDS-related Kaposi sarcoma
| Condition | Intervention |
|---|---|
|
Sarcoma |
Drug: bortezomib Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Single-Arm, Dose-Finding Pilot Trial of Single-Agent Bortezomib in Patients With Relapsed/Refractory AIDS-Associated Kaposi Sarcoma With Correlative Assessments of KSHV and HIV |
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood, saliva, and tumor tissue sample collection periodically for correlative biomarker studies, including measurement of KSHV viral loads, gene expression analysis, measurement of APOBEC3G levels by IHC, and RNA analysis by reverse transcriptase-PCR.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months for up to 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biopsy-proven cutaneous AIDS-related Kaposi sarcoma (KS)
Relapsed after or refractory to liposomal anthracycline
Has been on stable anti-retroviral therapy for ≥ 12 weeks that includes a protease inhibitor-based or non-nucleoside reverse transcriptase inhibitor-based regimen of ≥ 3 drugs AND has no intention to change the regimen for the duration of the study
PATIENT CHARACTERISTICS:
No acute or known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)
NOTE: **If the elevated bilirubin is felt to be secondary to indinavir or atazanavir therapy, then patients will be allowed on study without any limit on the total bilirubin provided the direct bilirubin is normal.
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| Principal Investigator: | Erin G. Reid, MD | University of California, San Diego |
More Information
| Responsible Party: | UCLA Clinical AIDS Research and Education (CARE) Center ( Ronald T. Mitsuyasu ) |
| Study ID Numbers: | CDR0000659554, AMC-063 |
| Study First Received: | November 18, 2009 |
| Last Updated: | January 28, 2010 |
| ClinicalTrials.gov Identifier: | NCT01016730 History of Changes |
| Health Authority: | Unspecified |
|
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Sarcoma, Kaposi Bortezomib Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |
Herpesviridae Infections Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms Therapeutic Uses Sarcoma Neoplasms, Vascular Tissue DNA Virus Infections |