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

A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Sponsoren

Hauptsponsor: Genta Incorporated

Quelle Genta Incorporated
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum June 2002
Phase Phase 2
Studientyp Interventional
Einschreibung 40
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: gallium nitrate

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Ort
Einrichtung: Genta
Standort Länder

United States

Überprüfungsdatum

February 2006

Schlüsselwörter
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov