Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma
5 other identifiers
interventional
93
1 country
2
Brief Summary
This phase II trial studies how well tipifarnib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for non-Hodgkin's lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2004
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 24, 2004
CompletedFirst Submitted
Initial submission to the registry
May 14, 2004
CompletedFirst Posted
Study publicly available on registry
May 19, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2009
CompletedResults Posted
Study results publicly available
December 7, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2017
CompletedApril 13, 2020
April 1, 2020
5.2 years
May 14, 2004
November 2, 2011
April 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses 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.
During the first 6 cycles of treatment
Secondary Outcomes (4)
Overall Survival
Up to 2 years
Time to Progression
up to 2 years
Duration of Response
up to 2 years
Number of Patients Who Experienced Grade 3 or 4 Toxicities
Up to 56 days
Study Arms (1)
Treatment (tipifarnib)
EXPERIMENTALPatients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Biopsy-proven relapsed or refractory lymphomas; previous biopsies =\< 6 months prior to treatment on this protocol will be acceptable as long as there has not been intervening therapy; if the patient has received therapy for non-Hodgkin's disease (NHL) between the time of the last biopsy and this protocol, then a re-biopsy is necessary
- STUDY 1: Aggressive lymphomas (permanently closed to accrual 6/28/06):
- Transformed lymphomas
- Diffuse large B cell lymphoma
- Mantle cell lymphoma
- Follicular lymphoma grade III STUDY 2: Indolent lymphomas (permanently closed to accrual 9/26/07)
- Small lymphocytic lymphoma/chronic lymphocytic leukemia
- Follicular lymphoma, grades 1, 2
- Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type
- Nodal marginal zone B-cell lymphoma
- Splenic marginal zone B-cell lymphoma
- STUDY 3: Uncommon lymphomas:
- Peripheral T cell lymphoma, unspecified
- Anaplastic large cell lymphoma (T and null cell type)
- Lymphoplasmacytic lymphoma
- +15 more criteria
You may not qualify if:
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breastfeeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- NOTE: The effects of R115777 on the developing human fetus at the recommended therapeutic dose are unknown
- Life-threatening illness (unrelated to tumor)
- Ongoing radiation therapy or radiation therapy =\< 3 weeks prior to study registration unless the acute side effects associated with such therapy are resolved
- Therapy with myelosuppressive chemotherapy, cytotoxic chemotherapy, or biologic therapy =\< 3 weeks (6 weeks for nitrosourea or mitomycin C) or corticosteroids =\< 2 weeks, prior to starting R11577; patients may be on corticosteroids or tapering off them up until the day they start R11577 as long as it is clear that they are not having a tumor response to the steroids or that the steroids would confuse the interpretation of response to R11577; patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or intractable symptoms of lymphoma
- Peripheral neuropathy \>= grade 3
- Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives
- Presence of central nervous system (CNS) lymphoma
- Other active malignancies
- Once a patient begins FTI (tipifarnib) treatment, the addition of other cancer treatment will confound the assessment of efficacy and therefore is not allowed; this restriction precludes the addition of cytotoxic, immunologic agents, radiotherapy, or an increase in corticosteroid dose while the patient is in the treatment phase of this protocol
- Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required but should be done if clinically indicated; HIV patients are excluded because of concerns regarding excess risk of complications of immunosuppressive therapy regimens
- Known allergy to imidazole drugs such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, sulconazole, tioconazole, or terconazole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Witzig TE, Tang H, Micallef IN, Ansell SM, Link BK, Inwards DJ, Porrata LF, Johnston PB, Colgan JP, Markovic SN, Nowakowski GS, Thompson CA, Allmer C, Maurer MJ, Gupta M, Weiner G, Hohl R, Kurtin PJ, Ding H, Loegering D, Schneider P, Peterson K, Habermann TM, Kaufmann SH. Multi-institutional phase 2 study of the farnesyltransferase inhibitor tipifarnib (R115777) in patients with relapsed and refractory lymphomas. Blood. 2011 Nov 3;118(18):4882-9. doi: 10.1182/blood-2011-02-334904. Epub 2011 Jul 1.
PMID: 21725056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas E. Witzig, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas E Witzig
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2004
First Posted
May 19, 2004
Study Start
March 24, 2004
Primary Completion
May 20, 2009
Study Completion
July 5, 2017
Last Updated
April 13, 2020
Results First Posted
December 7, 2011
Record last verified: 2020-04