Back to resultsStudy of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma
Primary Purpose
Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Canfosfamide HCl for injection
Sponsored by
About this trial
This is an interventional treatment trial for Mantle Cell Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
- Cancer Institute of New Jersey
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Mantle Cell Lymphoma
Diffuse Large B Cell Lymphoma
Multiple Myeloma
Arm Description
Patients with relapsed or refractory mantle cell lymphoma
Patients with relapsed or refractory diffuse large B cell lymphoma
Patients with relapsed or refractory multiple myeloma
Outcomes
Primary Outcome Measures
Objective Response Rate
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
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
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
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
Duration of response will be determined after disease progression is documented in patients who have an objective response.
Safety Assessments
Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148108
Brief Title
Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Telik
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, B Cell Lymphoma, Multiple Myeloma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mantle Cell Lymphoma
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory mantle cell lymphoma
Arm Title
Diffuse Large B Cell Lymphoma
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory diffuse large B cell lymphoma
Arm Title
Multiple Myeloma
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory multiple myeloma
Intervention Type
Drug
Intervention Name(s)
Canfosfamide HCl for injection
Other Intervention Name(s)
Telcyta, TLK286
Intervention Description
30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
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.
Time Frame
At 6 weeks of treatment
Title
Objective Response Rate
Description
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.
Time Frame
At 12 weeks of treatment
Title
Objective Response Rate
Description
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.
Time Frame
At 18 weeks of treatment
Title
Objective Response Rate
Description
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.
Time Frame
At 24 weeks of treatment
Secondary Outcome Measure Information:
Title
Duration of Response
Description
Duration of response will be determined after disease progression is documented in patients who have an objective response.
Time Frame
At 6, 12, 18 & 24 weeks of treatment
Title
Safety Assessments
Description
Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.
Time Frame
At 3, 6, 9, & 12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bertino, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma
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