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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Allopurinol; Camptothecin; Gemcitabine; Irinotecan

Criteria

Inclusion Criteria:

1. Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.

2. Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.

3. 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.

4. The patient must have bidimensionally measurable or evaluable disease.

5. Age > 18 years.

6. ECOG Performance status < 2

7. Informed consent.

8. ANC > 1.5, platelet count > 100K, creatinine< 2.0, bilirubin < 3

9. Female patients must have a negative pregnancy test.