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
|
