Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma

Sponsor

Genta Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT00054808

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Relapsed Lymphoma Refractory Lymphoma Low-Grade Lymphoma Intermediate-Grade Lymphoma	Drug: gallium nitrate	Phase 2

Detailed Description

This study seeks to define the role of gallium nitrate in a specific population of patients who are expected to have received prior therapy. Preliminary clinical studies have suggested substantial evidence of antitumor activity in patients with relapsed or refractory non-Hodgkin's Lymphoma treated with gallium nitrate.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Study Start Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Low- or intermediate-grade NHL using the International Working Formulation, subtypes IWF

A-G:

Using the Updated REAL/WHO Classification, the following pathologic subtypes are eligible:

Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma/immunocytoma
Follicular lymphoma
Diffuse large B-cell lymphoma
Peripheral T-cell lymphoma, not otherwise characterized

Progression of disease following treatment with standard chemotherapy

Bi-dimensionally measurable disease

Performance Status: ECOG < = 2

Patients with mantle cell lymphoma or mycosis fungoides are not eligible

Patients with known history of CNS metastasis are not eligible

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Genta	Berkeley Heights	New Jersey	United States	07922

Sponsors and Collaborators

Genta Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Warrell RP Jr, Coonley CJ, Straus DJ, Young CW. Treatment of patients with advanced malignant lymphoma using gallium nitrate administered as a seven-day continuous infusion. Cancer. 1983 Jun 1;51(11):1982-7.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00054808

Other Study ID Numbers:

Genta-GGN202

First Posted:

Feb 13, 2003

Last Update Posted:

Feb 8, 2006

Last Verified:

Feb 1, 2006

Keywords provided by , ,

Additional relevant MeSH terms:

Lymphoma

Lymphoma, Non-Hodgkin

Gallium nitrate

Study Results

No Results Posted as of Feb 8, 2006