NCT00124605

Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma

Phase I Trial of Arsenic Trioxide in Combination With Pamidronate Disodium

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with pamidronate may kill more cancer cells. This phase I trial is studying the side effects and best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors or multiple myeloma

Detailed description

PRIMARY OBJECTIVES: I. To describe the toxicities of the combination of arsenic trioxide in combination with pamidronate disodium at four dose levels. II. To assess the pharmacokinetics of pamidronate disodium when given in combination with arsenic trioxide. III. Utilizing 2-color immunofluorescence (IF) to determine if the treatment with combination of arsenic trioxide and pamidronate disodium affects the phosphorylation of epidermal growth factor receptor (EGFR) IV. In patients with multiple myeloma utilizing western blot to evaluate the pre- and post-treatment levels of protein tyrosine phosphatase 1B in lysates of multiple myeloma cells. V. To obtain preliminary data for response to this regimen in this patient population. OUTLINE: This is a dose-escalation, multicenter study. Patients receive pamidronate IV and over 2 hours on days 1 and 15 and arsenic trioxide IV over 2 hours on days 1-5 and 15-19. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pamidronate and arsenic trioxide 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. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study.

Conditions

• Refractory Multiple Myeloma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pamidronate disodium	Given IV
DRUG	arsenic trioxide	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-06-01
• First posted: 2005-07-28
• Last updated: 2013-01-07

Locations

1 site across 1 country: United States