Trials / Completed
CompletedNCT00054808
Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma
A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Genta Incorporated · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non-Hodgkin's Lymphoma
- Relapsed Lymphoma
- Refractory Lymphoma
- Low-Grade Lymphoma
- Intermediate-Grade Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gallium nitrate |
Timeline
- Start date
- 2002-06-01
- First posted
- 2003-02-13
- Last updated
- 2006-02-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00054808. Inclusion in this directory is not an endorsement.