NCT00054808

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2003

Completed
Last Updated

February 8, 2006

Status Verified

February 1, 2006

First QC Date

February 10, 2003

Last Update Submit

February 7, 2006

Conditions

Non-Hodgkin's LymphomaRelapsed LymphomaRefractory LymphomaLow-Grade LymphomaIntermediate-Grade Lymphoma

Keywords

Gallium NitrateGaniteNHLRelapsed

Interventions

gallium nitrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Genta

Berkeley Heights, New Jersey, 07922, United States

Location

Related 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. doi: 10.1002/1097-0142(19830601)51:113.0.co;2-l.

    PMID: 6839291BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphomaRecurrence

Interventions

gallium nitrate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2003

First Posted

February 13, 2003

Study Start

June 1, 2002

Last Updated

February 8, 2006

Record last verified: 2006-02

Locations

US(1)