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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082888 |
RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well tipifarnib works in treating patients with relapsed or refractory lymphoma.
Condition | Intervention | Phase |
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Leukemia Lymphoma |
Drug: tipifarnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Evaluation Of FTI (RII5777) In Treatment Of Relapsed And Refractory Lymphoma |
Estimated Enrollment: | 123 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive [closed to accrual as of 6/28/2006] vs indolent [closed to accrual as of 9/26/2007] vs uncommon).
Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months until disease progression and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 41-123 patients (12-41 with aggressive lymphoma [closed to accrual as of 6/28/2006], 17-41 with indolent lymphoma [closed to accrual as of 9/26/2007], and 12-41 with uncommon lymphoma) will be accrued for this study within 6-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-Hodgkin's or Hodgkin's lymphoma
The following histologies are eligible:
Aggressive lymphoma (closed to accrual as of 6/28/2006)
Indolent lymphoma (closed to accrual as of 9/26/2007)
Uncommon lymphoma
Measurable disease, defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1002 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
Responsible Party: | M. D. Anderson Cancer Center at University of Texas ( Francis J. Giles ) |
Study ID Numbers: | CDR0000360887, MAYO-LS038B, NCI-6246 |
Study First Received: | May 14, 2004 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00082888 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent adult diffuse large cell lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent mycosis fungoides/Sezary syndrome refractory chronic lymphocytic leukemia anaplastic large cell lymphoma Waldenstrom macroglobulinemia |
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma recurrent adult Hodgkin lymphoma |
Leukemia, Lymphoid Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Follicular Lymphoma Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Mycoses Cutaneous T-cell Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic |
Lymphoma, Large-cell Leukemia, B-cell, Chronic Hodgkin Disease Lymphoma Tipifarnib Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia B-cell Lymphomas Anaplastic Large Cell Lymphoma |
Lymphatic Diseases Leukemia Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Antineoplastic Agents Therapeutic Uses Lymphoproliferative Disorders Lymphoma Pharmacologic Actions Tipifarnib |