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

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:

MedlinePlus related topics: Cancer Lymphoma Multiple Myeloma

U.S. FDA Resources

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

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

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
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 21, 2013