Cancer Clinical Trial
Official title:
Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma
RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells.
Giving sodium stibogluconate together with interferon may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sodium
stibogluconate when given together with interferon in treating patients with advanced solid
tumors, lymphoma, or myeloma.
OBJECTIVES:
Primary
- Confirm the tolerance, safety, and maximum tolerated dose of sodium stibogluconate (SSG)
in combination with interferon alfa-2b in patients with advanced solid tumors, lymphoma,
or myeloma.
Secondary
- Quantify the effect of SSG on interferon alfa-2b-induced gene modulation and signal
transduction pathways by measurement of the serum-soluble gene products β-2
microglobulin, immune serum globulin 15, and neopterin.
- Define the effectiveness of SSG in inhibiting the protein tyrosine phosphatases src
homology proteins (SHP)-1 and SHP-2 assayed from peripheral blood leukocytes of patients
receiving SSG in combination with interferon alfa-2b.
- Define pharmacokinetics of SSG in serum at escalating doses.
- Assess clinical response to the combination of SSG and interferon alfa-2b.
OUTLINE: This is an open-label, dose-escalation study of sodium stibogluconate (SSG).
Patients receive SSG IV over 15 minutes on days 1, 15-19, and 22-26 and interferon alfa-2b
subcutaneously daily on days 8-12 and 15-28. Treatment repeats every 6 weeks in the absence
of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of SSG 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.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
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