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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Hodgkin's Lymphoma, Cancer

Intervention / Treatment
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* Drug: Gemcitabine, Irinotecan, Allopurinol.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess progression free survival in these patients with this regimen. |  | 3 years | 
| Assess toxicity of this regimen in this group of patients. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma-Non Hodgkins, Phase II, Gemcitabine, Irinotecan