Back to resultsINST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Primary Purpose
Non-Hodgkin's Lymphoma, Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Irinotecan, Allopurinol.
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan
Eligibility 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.
Sites / Locations
- Lovelace Sandia Health Systems Dept of Hematology
- University of New Mexico
Outcomes
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.
Secondary Outcome Measures
Assess progression free survival in these patients with this regimen.
Assess toxicity of this regimen in this group of patients.
Full Information
NCT ID
NCT00276003
First Posted
January 11, 2006
Last Updated
January 6, 2010
Sponsor
University of New Mexico
1. Study Identification
Unique Protocol Identification Number
NCT00276003
Brief Title
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Official Title
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of New Mexico
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Cancer
Keywords
Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Irinotecan, Allopurinol.
Intervention Description
Gemcitabine - 1000mg/m2; IV; d1, 8; q 21 days Irinotecan - 100mg/m2; IV; d1, 8; q 21 days Allopurinol - 300 mg; PO; day 1-5; 1st cycle
Primary Outcome Measure Information:
Title
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Assess progression free survival in these patients with this regimen.
Time Frame
3 years
Title
Assess toxicity of this regimen in this group of patients.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Rabinowitz, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lovelace Sandia Health Systems Dept of Hematology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
We'll reach out to this number within 24 hrs