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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276003
• Other study ID #: 0101C
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2006
• Last updated: January 6, 2010
• Start date: August 2002
• Est. completion date: August 2005

Study information

• Verified date: December 2009
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Gemcitabine, Irinotecan, Allopurinol.
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

Locations

Country	Name	City	State
United States	Lovelace Sandia Health Systems Dept of Hematology	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assess progression free survival in these patients with this regimen.		3 years	No
Secondary	Assess toxicity of this regimen in this group of patients.		3 years	No