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

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT00276003

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma Cancer	Drug: Gemcitabine, Irinotecan, Allopurinol.	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2002

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

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. [3 years]

Secondary Outcome Measures

Assess progression free survival in these patients with this regimen. [3 years]
Assess toxicity of this regimen in this group of patients. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lovelace Sandia Health Systems Dept of Hematology	Albuquerque	New Mexico	United States	87108
2	University of New Mexico	Albuquerque	New Mexico	United States	87131