Phase II Gallium Nitrate in Relapsed or Refractory NCT00054808

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00054808
Other study ID #	Genta-GGN202
Secondary ID
Status	Completed
Phase	Phase 2
First received	February 10, 2003
Last updated	February 7, 2006
Start date	June 2002

Study information
Verified date	February 2006
Source	Genta Incorporated
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	40
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gallium nitrate

Locations
Country	Name	City	State
United States	Genta	Berkeley Heights	New Jersey

Sponsors *(1)*
Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

United States,

References & Publications (1)

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. — View Citation

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

Clinical Trial Details — Status: Completed

Administrative data

Study information