Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma

Sponsor

Pharmacyclics LLC. (Industry)

Overall Status

Completed

CT.gov ID

NCT00086034

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Non-Hodgkin's Lymphoma	Drug: Motexafin gadolinium	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcome Measures

Clinical response rate []

Secondary Outcome Measures

Progression-free survival []
Duration of clinical response []
Safety and tolerability []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 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

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	San Diego	California	United States	92121
2	Stanford	California	United States	94305
3	Miami	Florida	United States	33136
4	Chicago	Illinois	United States	60611
5	Baltimore	Maryland	United States	21231
6	Rochester	Minnesota	United States	55905
7	Madison	Wisconsin	United States	53792