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

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ClinicalTrials.gov Identifier: NCT00276003
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : January 7, 2010
Sponsor:
Information provided by:
University of New Mexico

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2002
Actual Primary Completion Date : June 2005
Actual Study Completion Date : August 2005



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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 Measures :
  1. Assess progression free survival in these patients with this regimen. [ Time Frame: 3 years ]
  2. Assess toxicity of this regimen in this group of patients. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276003


Locations
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United States, New Mexico
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States, 87108
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Ian Rabinowitz, MD University of New Mexico

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Responsible Party: Ian Rabinowitz, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00276003     History of Changes
Other Study ID Numbers: 0101C
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: December 2009

Keywords provided by University of New Mexico:
Lymphoma-Non Hodgkins
Phase II
Gemcitabine
Irinotecan

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Irinotecan
Allopurinol
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents