Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Soren Gantt

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AIDS Malignancy Consortium

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This pilot phase II trial studies how well nelfinavir mesylate works in treating patients with kaposi sarcoma. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

Soren Gantt

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

Inclusion Criteria

Biopsy-proven KS involving skin (with or without visceral involvement) without need for urgent cytotoxic therapy; there should be no evidence of improvement in KS in the 4 weeks immediately prior to study enrollment

Approved diagnostic tests, or The referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection

Participants enrolled outside the U.S. must have a confirmatory diagnostic test sequence as appropriate per national standards, detailed as above, performed regardless of prior documented HIV status; for HIV-negative participants, testing must be performed no more than 1 month prior to study enrollment; NOTE: the term "licensed" refers to a U.S. Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally; WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme/chemiluminescence immunoassay (E/CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 ribonucleic acid (RNA) viral load

Treatment Details

Interventions

• Nelfinavir Mesylate (Protease Inhibitor)

Participant Groups

Group I: Treatment (nelfinavir mesylate) Experimental Treatment 2 Interventions

DOSE NELFINAVIR MESYLATE: Patients receive standard dose nelfinavir mesylate PO BID for 4 weeks in the absence of PD. Patients with PD at 4 weeks proceed to high-dose nelfinavir. At week 8, if there is SD or PR, patients advance to high-dose nelfinavir mesylate. Patients discontinue standard dose nelfinavir mesylate 4 weeks after documentation of CR. HIGH DOSE NELFINAVIR MESYLATE: Patients with PD continue to receive high-dose nelfinavir mesylate PO BID for 4 more weeks. If there is PD documented after 4 weeks at the high dose level, nelfinavir is discontinued. If there is SD or PR, patients continue receiving nelfinavir mesylate for 16 weeks. If there is CR, patients discontinue high-dose nelfinavir mesylate 4 weeks after documentation of CR.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Beth Israel Deaconess Medical Center Boston, MA

University of Miami Miami, FL

Washington University School of Medicine Saint Louis, MO

Ohio State University Columbus, OH

More Trial Locations

Who Is Running the Clinical Trial?

AIDS Malignancy Consortium

Lead Sponsor

Trials

64

Patients Recruited

9,600+

Montefiore Medical Center

Collaborator

Trials

468

Patients Recruited

599,000+

University of Arkansas

Collaborator

Trials

500

Patients Recruited

153,000+

AIDS and Cancer Specimen Resource

Collaborator

Trials

8

Patients Recruited

990+

University of California, Los Angeles

Collaborator

Trials

1594

Patients Recruited

10,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Patients Recruited

1,052,000+