NCT00086034

Brief Summary

The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2 lymphoma

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2004

Completed
Last Updated

May 15, 2007

Status Verified

May 1, 2007

First QC Date

June 21, 2004

Last Update Submit

May 11, 2007

Conditions

LymphomaNon-Hodgkin's Lymphoma

Keywords

LymphomaNon-Hodgkin's LymphomaIndolent lymphomaRelapsed lymphomaRefractory lymphomaMotexafin gadolinium

Outcome Measures

Primary Outcomes (1)

  • Clinical response rate

Secondary Outcomes (3)

  • Progression-free survival

  • Duration of clinical response

  • Safety and tolerability

Interventions

Motexafin gadoliniumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old
  • Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
  • Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
  • ECOG performance status score either 0 or 1
  • Willing and able to provide written informed consent

You may not qualify if:

  • Laboratory values of:
  • Platelet count \< 50,000/µL
  • AST or ALT \> 2 x the upper limit of normal (ULN)
  • Total bilirubin \> 2 x ULN
  • Creatinine \> 2.0 mg/dL
  • and
  • Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
  • Uncontrolled hypertension
  • Known history of porphyria, G6PD deficiency, HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

San Diego, California, 92121, United States

Location

Unknown Facility

Stanford, California, 94305, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Baltimore, Maryland, 21231, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Non-Hodgkin

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Brad Kahl, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 21, 2004

First Posted

June 23, 2004

Last Updated

May 15, 2007

Record last verified: 2007-05

Locations

US(7)