Sarcoma Clinical Trial
Official title:
A Pilot Study of Rapamycin in Patients With HIV-Related Kaposi's Sarcoma
RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Sirolimus also 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 pilot study is studying sirolimus in treating patients with HIV-related
Kaposi's sarcoma.
OBJECTIVES:
Primary
- Determine the safety and toxicity of sirolimus in patients with HIV-related Kaposi's
sarcoma (KS) receiving protease inhibitor (PI)-based or nonnucleoside reverse
transcriptase inhibitor (NNRTI)-based highly active antiretroviral treatment (HAART)
regimens.
- Estimate the dose(s) of this drug required to achieve target trough sirolimus plasma
concentrations of 5-10 ng/mL in patients receiving PI-based or NNRTI-based HAART
regimens.
Secondary
- Evaluate the clinical response of KS in patients treated with this sirolimus.
- Determine the effects of this drug on mTOR-dependent signaling in peripheral blood
mononuclear cells (PBMC) and KS tumor biopsies.
- Determine the serum cytokine profiles pre- and post-treatment with this drug.
- Determine the effects of this drug on HIV and KS-associated herpesvirus (KSHV) viral
loads.
- Determine the effects of this drug on T-lymphocyte subsets.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups.
- Group 1 (patients receiving PI-based HAART regimen with ritonavir): Patients receive
oral sirolimus 0.0015 mg/kg/day once daily on days 1-28 for 6 courses as long as KS is
stable or the disease is continuing to respond to treatment. Patients may receive 6
additional courses provided they meet criteria for response in the absence of disease
progression or unacceptable toxicity. Patients with no more than stable disease after 6
courses are discontinued from treatment.
- Group 2 (patients receiving PI-based HAART regimen without ritonavir): Patients receive
oral sirolimus 0.003 mg/kg/day as in group 1.
- Group 3 (patients receiving NNRTI-based HAART regimen): Patients receive oral sirolimus
0.05 mg/kg/day as in group 1.
Blood samples are collected periodically and analyzed for sirolimus levels via LCMSMS.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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