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

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00276003

Purpose

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	Intervention	Phase
Non-Hodgkin's Lymphoma Cancer	Drug: Gemcitabine, Irinotecan, Allopurinol.	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

Drug Information available for: Allopurinol sodium Gemcitabine Irinotecan U 101440E Gemcitabine hydrochloride Irinotecan hydrochloride Allopurinol

U.S. FDA Resources

Further study details as provided by University of New Mexico:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess progression free survival in these patients with this regimen. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Assess toxicity of this regimen in this group of patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	August 2002
Study Completion Date:	August 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276003

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States, 87108

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Ian Rabinowitz, MD

University of New Mexico

More Information

No publications provided

Responsible Party:	University of New Mexico - CRTC ( Ian Rabinowitz, MD; Principal Investigator )
Study ID Numbers:	0101C
Study First Received:	January 11, 2006
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00276003 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Lymphoma-Non Hodgkins
Phase II
Gemcitabine
Irinotecan

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Allopurinol
Immunoproliferative Disorders
Antioxidants
Immunologic Factors
Irinotecan
Immunosuppressive Agents
Antiviral Agents

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Radiation-Sensitizing Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Gemcitabine
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Lymphoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Allopurinol
Antioxidants
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Gout Suppressants
Therapeutic Uses
Free Radical Scavengers
Gemcitabine
Lymphoma

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Immunosuppressive Agents
Protective Agents
Antiviral Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Radiation-Sensitizing Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009