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



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

For Condition: Non-Hodgkin's Lymphoma,Relapsed Lymphoma,Refractory Lymphoma,Intermediate-Grade Lymphoma,Low-Grade Lymphoma
Status: Recruiting
Sponsor(s): Genta ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 40

Location and Contact Information:

Genta *Recruiting*
Berkeley Heights,  New Jersey,  07922
United States
Recruiting Jean  Farrell 1-888-TO-GENTA


Additional Information:
Study ID Numbers:
  Genta-GGN202; 
Study Start Date: June 2002
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054808

Other Low-Grade Lymphoma Studies:
1. Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

2. Bioequivalence Study of Tellurium-Derived Vs. Fission-Derived Iodine I 131 Tositumomab for Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma

3. Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma

4. Combination Chemotherapy With or Without Rituximab in Treating Older Patients With Non-Hodgkin's Lymphoma

5. Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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

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