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

This study has been completed.
Sponsor:
Information provided by:
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00054808
First received: February 10, 2003
Last updated: February 7, 2006
Last verified: February 2006
  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 Intervention Phase
Non-Hodgkin's Lymphoma
Relapsed Lymphoma
Refractory Lymphoma
Low-Grade Lymphoma
Intermediate-Grade Lymphoma
Drug: gallium nitrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Estimated Enrollment: 40
Study Start Date: June 2002
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054808

Locations
United States, New Jersey
Genta
Berkeley Heights, New Jersey, United States, 07922
Sponsors and Collaborators
Genta Incorporated
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00054808     History of Changes
Other Study ID Numbers: Genta-GGN202
Study First Received: February 10, 2003
Last Updated: February 7, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Genta Incorporated:
Gallium Nitrate
Ganite
NHL
Relapsed

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gallium nitrate
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014