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

Sponsored by:	Genta Incorporated
Information provided by:	Genta Incorporated
ClinicalTrials.gov Identifier:	NCT00054808

Purpose

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	Intervention	Phase
Non-Hodgkin's Lymphoma Relapsed Lymphoma Refractory Lymphoma Low-Grade Lymphoma Intermediate-Grade Lymphoma	Drug: gallium nitrate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Efficacy Study
Official Title:	A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Gallium nitrate Gallium

U.S. FDA Resources

Further study details as provided by Genta Incorporated:

Estimated Enrollment:	40
Study Start Date:	June 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054808

Locations

United States, New Jersey
Genta
Berkeley Heights, New Jersey, United States, 07922

Sponsors and Collaborators

Genta Incorporated

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.

Study ID Numbers:	Genta-GGN202
Study First Received:	February 10, 2003
Last Updated:	February 7, 2006
ClinicalTrials.gov Identifier:	NCT00054808 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genta Incorporated:

Gallium Nitrate
Ganite
NHL
Relapsed

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Gallium nitrate

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Gallium nitrate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009