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Completed

NCT Number: NCT01148108

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

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.

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Key information

Conditions

Mantle Cell Lymphoma B Cell Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canfosfamide HCl for injection

Drug

30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks

Other names: Telcyta, TLK286

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2010
Registry last updated
Mar 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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