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

Multiple Myeloma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148108
• Other study ID #: TLK286.2030
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2010
• Last updated: March 13, 2013
• Start date: June 2010
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Canfosfamide HCl for injection
30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 6 weeks of treatment	No
Primary	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.	At 12 weeks of treatment	No
Primary	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.	At 18 weeks of treatment	No
Primary	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.	At 24 weeks of treatment	No
Secondary	Duration of Response	Duration of response will be determined after disease progression is documented in patients who have an objective response.	At 6, 12, 18 & 24 weeks of treatment	No
Secondary	Safety Assessments	Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.	At 3, 6, 9, & 12 weeks of treatment	No