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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT01148108
First received: June 17, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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:


Further study details as provided by Telik:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 14
Study Start Date: June 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Telik
Investigators
Principal Investigator: Joseph Bertino, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT01148108     History of Changes
Other Study ID Numbers: TLK286.2030
Study First Received: June 17, 2010
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
NHL
Non-Hodgkins Lymphoma
Lymphoma
Mantle Cell
Diffuse Large B Cell
Multiple Myeloma
Telcyta
canfosfamide
TLK286
Prodrug
Enzyme activated drug
Glutathione Transferase P1-1 activated drug
GSTp1-1 activated drug
Glutathione Transferase activated drug
Glutathione
Glutathione analong

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014