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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ian Rabinowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

0101C

NCT ID:

NCT00276003

Start Date:

August 2002

Completion Date:

August 2005

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Cancer
  • Lymphoma-Non Hodgkins
  • Phase II
  • Gemcitabine
  • Irinotecan
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
University of New Mexico Albuquerque, New Mexico  87131
Lovelace Sandia Health Systems Dept of Hematology Albuquerque, New Mexico  87108