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

NCT01148108 | Completed Phase 2 DMC

• 1 other identifier: TLK286.2030
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Mantle Cell Lymphoma; B Cell Lymphoma; Multiple Myeloma

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• Duration of Response

  At 6, 12, 18 & 24 weeks of treatment

• Safety Assessments

  At 3, 6, 9, & 12 weeks of treatment

Study Arms (3)

Mantle Cell Lymphoma

EXPERIMENTAL

Patients with relapsed or refractory mantle cell lymphoma

Drug: Canfosfamide HCl for injection

Diffuse Large B Cell Lymphoma

EXPERIMENTAL

Patients with relapsed or refractory diffuse large B cell lymphoma

Drug: Canfosfamide HCl for injection

Multiple Myeloma

EXPERIMENTAL

Patients with relapsed or refractory multiple myeloma

Drug: Canfosfamide HCl for injection

Interventions

Canfosfamide HCl for injection DRUG

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

Also known as: Telcyta, TLK286

Diffuse Large B Cell Lymphoma; Mantle Cell Lymphoma; Multiple Myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Telik: lead

Study Sites (1)

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, B-Cell; Multiple Myeloma; Lymphoma, Non-Hodgkin; Lymphoma

Interventions

TER 286; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Joseph Bertino, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

US (1)