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RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.
- Determine the safety of recombinant interleukin-7 (IL-7) in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma.
- Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients.
- Determine the safety of higher doses of recombinant IL-7 in these patients.
- Determine the maximum tolerated dose of recombinant IL-7 in these patients.
- Determine the biologically active dose of recombinant IL-7 in these patients.
- Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients.
- Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients.
- Determine the potential antitumor effect of recombinant IL-7 in these patients.
- Determine the dose and administration schedule of recombinant IL-7 in these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to lymphocyte count (normal lymphocyte count [CD4+ T cells > 400/mm^3] vs lymphopenic [CD4+ T cells < 400/mm^3]). Patients are assigned to 1 of 2 treatment groups.
- Group 1 (normal lymphocyte count): Patients receive recombinant interleukin-7 (IL-7) subcutaneously once a week (to determine an active dose) for up to 3 weeks in the absence of disease progression or unacceptable toxicity.
- Group 2 (lymphopenic): Patients receive recombinant IL-7 subcutaneously once a week for up to 3 weeks at one dose level below the active dose determined in group 1.
Cohorts of 3-6 patients from each group receive escalating doses of recombinant IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is the defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 30 additional patients may be treated at the MTD.
Patients undergo blood and bone marrow collection periodically for pharmacokinetic, pharmacodynamic, and immunological studies. Samples are analyzed for the presence of antibodies and proteins via ELISA; CD3, CD4, and CD8 T cell counts, CD127, Ki-67, and Bcl-2 expression in CD4+ and CD8+ T cells, and CD19 B cell counts via flow cytometry; and clonal B cell proliferation via PCR and flow cytometry.
After completion of study treatment, patients are followed at 3 months.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
recombinant interleukin-7, gene expression analysis, polymerase chain reaction, protein expression analysis, flow cytometry, immunoenzyme technique, immunologic technique, laboratory biomarker analysis, pharmacological study
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Published on BioPortfolio: 2014-08-27T03:37:46-0400
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