NCT01148108 - Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

14

Conditions

Mantle Cell Lymphoma B Cell Lymphoma Multiple Myeloma

Interventions

Canfosfamide HCl for injectionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: At 6 weeks of treatment

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.

Time frame: At 12 weeks of treatment

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.

Time frame: At 18 weeks of treatment

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.

Time frame: At 24 weeks of treatment

Secondary Outcomes

Duration of Response