Back to resultsPhase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma, Relapsed Lymphoma, Refractory Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gallium nitrate
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Gallium Nitrate, Ganite, NHL, Relapsed
Eligibility 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
Sites / Locations
- Genta
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00054808
Brief Title
Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title
A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Genta Incorporated
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Relapsed Lymphoma, Refractory Lymphoma, Low-Grade Lymphoma, Intermediate-Grade Lymphoma
Keywords
Gallium Nitrate, Ganite, NHL, Relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gallium nitrate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Genta
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
6839291
Citation
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. doi: 10.1002/1097-0142(19830601)51:113.0.co;2-l.
Results Reference
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Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
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