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

This study is ongoing, but not recruiting participants.

First Received on June 17, 2010.  
Last Updated on April 23, 2012  
History of Changes
This Clinical Trial Sponsored By: Telik
Information provided by (Responsible Party): Telik
ClinicalTrials.gov Identifier: NCT01148108
 

Purpose for Clinical Trial

This is a Clinical Trial 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.

Condition Study Intervention Phase
Mantle Cell Lymphoma
B Cell Lymphoma
Multiple Myeloma
Drug: Canfosfamide HCl for injection Phase 2

Study Type: Study Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Lymphoma
Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures For Clinical Trial:

  • Objective Response Rate [ Time Frame: At 6 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures For Clinical Trial:

  • Duration of Response [ Time Frame: At 6, 12, 18 & 24 weeks of treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.

Estimated Enrollment: 45
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Mantle Cell Lymphoma

Patients with relapsed or refractory mantle cell lymphoma
Drug: Canfosfamide HCl for injection

30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
Other Names:
  • Telcyta
  • TLK286
Experimental: Diffuse Large B Cell Lymphoma

Patients with relapsed or refractory diffuse large B cell lymphoma
Drug: Canfosfamide HCl for injection

30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
Other Names:
  • Telcyta
  • TLK286
Experimental: Multiple Myeloma

Patients with relapsed or refractory multiple myeloma
Drug: Canfosfamide HCl for injection

30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
Other Names:
  • Telcyta
  • TLK286

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148108

Locations

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