Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerance, safety, and maximum tolerated dose at 1 week after each course
Ernest C. Borden, MD
The Cleveland Clinic
United States: Food and Drug Administration
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