B Cell Lymphoma, Mantle Cell Lymphoma, Multiple Myeloma
Conditions
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
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.
Interventions
DRUGCanfosfamide HCl for injection
30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
Sponsors
Telik
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed