Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik

Criteria

Inclusion Criteria:

• relapsed or refractory disease

• histologically or cytologically confirmed disease

• characteristic immunophenotypic profiles

• measurable disease (for lymphoma patients)

• ECOG performance status of 0-2

• adequate liver and kidney function

• adequate bone marrow reserves

• ineligible or unwilling to undergo autologous stem cell transplantation

Exclusion Criteria:

• failure to recover from any major surgery within 4 weeks of study entry

• pregnant or lactating women

• women of child-bearing potential not using reliable and appropriate contraception

• routine prophylactic use of G-CSF required within 2 weeks of study entry

• Grade 3 or higher peripheral neuropathy

• history of hepatitis B virus or HIV

• central nervous system or meningeal involvement by lymphoma or multiple myeloma