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

NCT ID: NCT01148108

Last Updated: 2013-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mantle Cell Lymphoma B Cell Lymphoma Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mantle Cell Lymphoma

Patients with relapsed or refractory mantle cell lymphoma

Group Type EXPERIMENTAL

Canfosfamide HCl for injection

Intervention Type DRUG

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

Diffuse Large B Cell Lymphoma

Patients with relapsed or refractory diffuse large B cell lymphoma

Group Type EXPERIMENTAL

Canfosfamide HCl for injection

Intervention Type DRUG

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

Multiple Myeloma

Patients with relapsed or refractory multiple myeloma

Group Type EXPERIMENTAL

Canfosfamide HCl for injection

Intervention Type DRUG

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

Interventions

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Canfosfamide HCl for injection

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

Intervention Type DRUG

Other Intervention Names

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Telcyta TLK286

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph Bertino, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

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Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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TLK286.2030

Identifier Type: -

Identifier Source: org_study_id

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