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

Information source: Genta Incorporated
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma; Relapsed Lymphoma; Refractory Lymphoma; Low-Grade Lymphoma; Intermediate-Grade Lymphoma

Intervention: gallium nitrate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Genta Incorporated

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.

Clinical Details

Official title: A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Genta, Berkeley Heights, New Jersey 07922, United States
Additional Information

Related 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.

Starting date: June 2002
Last updated: February 7, 2006

Page last updated: August 20, 2015

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