Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
|Anaplastic Large Cell Lymphoma Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma Nodal Marginal Zone Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult T-Cell Leukemia/Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma||Other: Laboratory Biomarker Analysis Drug: Tipifarnib||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma|
- Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment [ Time Frame: During the first 6 cycles of treatment ]Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.
- Overall Survival [ Time Frame: Up to 2 years ]Overall survival time was defined as the time from registration to the date of death or last follow-up.
- Time to Progression [ Time Frame: up to 2 years ]Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation.
- Duration of Response [ Time Frame: up to 2 years ]Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.
- Toxicity [ Time Frame: 3/26/2004 - 2/1/2011 ]Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0
|Actual Study Start Date:||March 24, 2004|
|Primary Completion Date:||May 20, 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (tipifarnib)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Tipifarnib
I. To assess tumor response to R115777 (tipifarnib) in patients with relapsed aggressive non-Hodgkin's lymphoma. (Permanently closed to accrual 6/28/06) II. To assess tumor response to R115777 in patients with relapsed indolent non-Hodgkin's lymphoma. (Permanently closed to accrual 9/26/07) III. To assess tumor response to R115777 in patients with uncommon non-Hodgkin's lymphomas.
IV. To evaluate toxicity associated with this regimen in patients with relapsed non-Hodgkin's lymphoma.
I. To evaluate known and unknown molecular markers that may predict for response to R115777 in lymphoma tissue.
Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082888
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Thomas Witzig||Mayo Clinic|