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

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Relapsed Lymphoma; Refractory Lymphoma; Low-Grade Lymphoma; Intermediate-Grade Lymphoma

• Registration Number: NCT00054808
• Lead Sponsor: Genta Incorporated

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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2003-02-10
• Study First Submitted QC: 2003-02-12
• Study First Posted: 2003-02-13
• Status Verified: 2006-02
• Last Update Submitted: 2006-02-07
• Last Update Posted: 2006-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Genta; 🇺🇸 Berkeley Heights, New Jersey, United States