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

Sponsor

Telik (Industry)

Overall Status

Completed

CT.gov ID

NCT01148108

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective Response Rate [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.
Objective Response Rate [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.
Objective Response Rate [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.
Objective Response Rate [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 Outcome Measures

Duration of Response [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.
Safety Assessments [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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