INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.

University of New Mexico (UNM)

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Cancer

Treatments

Drug: Gemcitabine, Irinotecan, Allopurinol.

Study type

Interventional

Funder types

Other

Identifiers

NCT00276003

0101C

Details and patient eligibility

About

Primary objectives

Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.

Secondary objectives

Assess progression free survival in these patients treated with this regimen.
Assess toxicity of this regimen in this group of patients.

Full description

The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
The patient must have bidimensionally measurable or evaluable disease.
Age > 18 years.
ECOG Performance status < 2
Informed consent.
ANC > 1.5, platelet count > 100K, creatinine< 2.0, bilirubin < 3
Female patients must have a negative pregnancy test.