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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054808
Recruitment Status : Completed
First Posted : February 13, 2003
Last Update Posted : February 8, 2006
Information provided by:
Genta Incorporated

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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 : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054808

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United States, New Jersey
Berkeley Heights, New Jersey, United States, 07922
Sponsors and Collaborators
Genta Incorporated

Layout table for additonal information Identifier: NCT00054808    
Other Study ID Numbers: Genta-GGN202
First Posted: February 13, 2003    Key Record Dates
Last Update Posted: February 8, 2006
Last Verified: February 2006
Keywords provided by Genta Incorporated:
Gallium Nitrate
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gallium nitrate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antineoplastic Agents