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

March 13, 2013 updated by: Telik

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute Of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6 weeks of treatment
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.
At 12 weeks of treatment
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.
At 18 weeks of treatment
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.
At 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 6, 12, 18 & 24 weeks of treatment
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.
At 3, 6, 9, & 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Investigators

  • Principal Investigator: Joseph Bertino, MD, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 18, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLK286.2030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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