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OpenTrials
Completed

NCT Number: NCT00276003

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

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lovelace Sandia Health Systems Dept of Hematology, Albuquerque, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine, Irinotecan, Allopurinol.

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jan 12, 2006
Registry last updated
Jan 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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