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

This study is no longer recruiting patients.

Sponsored by: Genta
Information provided by: Genta

Purpose

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.

Condition Treatment or Intervention Phase
Non-Hodgkin's Lymphoma
Relapsed Lymphoma
Refractory Lymphoma
Low-Grade Lymphoma
Intermediate-Grade Lymphoma
 Drug: gallium nitrate
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  40

Study start: June 2002

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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


Location Information


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

More Information

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.

Study ID Numbers:  Genta-GGN202
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  February 10, 2003
ClinicalTrials.gov Identifier:  NCT00054808
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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