Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
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|ClinicalTrials.gov Identifier: NCT00082888|
Recruitment Status : Completed
First Posted : May 19, 2004
Results First Posted : December 7, 2011
Last Update Posted : April 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|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 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 Non-Hodgkin Lymphoma Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma||Other: Laboratory Biomarker Analysis Drug: Tipifarnib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma|
|Actual Study Start Date :||March 24, 2004|
|Actual Primary Completion Date :||May 20, 2009|
|Actual Study Completion Date :||July 5, 2017|
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
- Proportion of Participants With 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. Progression is defined as ≥50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or nonresponders or appearance of any new lesion during or at the end of therapy.
- 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 (CR) or partial response (PR) to the date progression (PD) is documented. CR:Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy PR:≥50% decrease in SPD of the six largest dominant nodes or nodal masses. PD:≥50 % increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders or appearance of any new lesion during or at the end of therapy.
- Number of Patients Who Experienced Grade 3 or 4 Toxicities [ Time Frame: Up to 56 days ]
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.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL(Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.).
Grade 4: Life-threatening consequences; urgent intervention indicated.
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): 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 E Witzig||Mayo Clinic|