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

Tracking Information
First Received Date ^ICMJE	February 10, 2003
Last Updated Date	February 7, 2006
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00054808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title ^ICMJE	A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Efficacy Study
Condition ^ICMJE	Non-Hodgkin's Lymphoma Relapsed Lymphoma Refractory Lymphoma Low-Grade Lymphoma Intermediate-Grade Lymphoma
Intervention ^ICMJE	Drug: gallium nitrate
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00054808
Responsible Party
Study ID Numbers ^ICMJE	Genta-GGN202
Study Sponsor ^ICMJE	Genta Incorporated
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genta Incorporated
Verification Date	February 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP