Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b for Solid Tumors, Lymphoma or Myeloma
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
Secondary
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.
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy, including, but not limited to, any of the following:
Stage IV disease
Refractory disease, resistant to established treatments, or no effective treatment available
Measurable or evaluable disease
CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Granulocyte count > 1,500/mm^3
Platelet count > 100,000/mm^3
Creatinine < 1.0 times upper limit of normal (ULN)
Creatinine clearance ≥ 60 mL/min
Bilirubin < 1.5 times ULN
AST/ALT < 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No history of any of the following:
No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS > 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec)
No systemic infections requiring antibiotics within the past 14 days
No known hepatitis B surface antigen positivity
Psychologically prepared to participate in study treatment
PRIOR CONCURRENT THERAPY: