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Sponsored by: |
Genta Incorporated |
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Information provided by: | Genta Incorporated |
ClinicalTrials.gov Identifier: | NCT00054808 |
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 |
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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 |
Estimated Enrollment: | 40 |
Study Start Date: | June 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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:
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
Study ID Numbers: | Genta-GGN202 |
Study First Received: | February 10, 2003 |
Last Updated: | February 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00054808 |
Health Authority: | United States: Food and Drug Administration |
Gallium Nitrate Ganite NHL Relapsed |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse Gallium nitrate |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |