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

Overview

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.

Full Title of Study: “Phase 2 Study of Canfosfamide HCl for Injection (Telcyta®, TLK286)in Refractory or Relapsed Mantle Cell Lymphoma (MCL), Diffuse Large B Cell Lymphoma (DLBCL) and Multiple Myeloma (MM)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Canfosfamide HCl for injection
    • 30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks

Arms, Groups and Cohorts

  • Experimental: Mantle Cell Lymphoma
    • Patients with relapsed or refractory mantle cell lymphoma
  • Experimental: Diffuse Large B Cell Lymphoma
    • Patients with relapsed or refractory diffuse large B cell lymphoma
  • Experimental: Multiple Myeloma
    • Patients with relapsed or refractory multiple myeloma

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate
    • Time Frame: At 6 weeks of treatment
    • Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.
  • Objective Response Rate
    • Time Frame: At 12 weeks of treatment
    • Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.
  • Objective Response Rate
    • Time Frame: At 18 weeks of treatment
    • Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.
  • Objective Response Rate
    • Time Frame: At 24 weeks of treatment
    • Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.

Secondary Measures

  • Duration of Response
    • Time Frame: At 6, 12, 18 & 24 weeks of treatment
    • Duration of response will be determined after disease progression is documented in patients who have an objective response.
  • Safety Assessments
    • Time Frame: At 3, 6, 9, & 12 weeks of treatment
    • Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Telik
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph Bertino, MD, Principal Investigator, Rutgers Cancer Institute of New Jersey

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