Completed

Assessment of Tipifarnib in Relapsed Non-Hodgkin's Lymphoma

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What is being tested

Laboratory Biomarker Analysis

+ Tipifarnib

OtherDrug
Who is being recruted

Chronic Disease+24

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 24, 2004

Actual date on which the first participant was enrolled.

This study focuses on evaluating a drug called R115777, also known as tipifarnib, for the treatment of relapsed non-Hodgkin's lymphoma. This includes aggressive, indolent, and uncommon types of non-Hodgkin's lymphoma. The main goal is to understand how well this drug works in shrinking tumors in patients who have not responded well to previous treatments. The study also aims to identify any potential side effects associated with this medication. The importance of this study lies in its potential to improve treatment options for patients with relapsed non-Hodgkin's lymphoma. Patients participating in this study will receive tipifarnib orally, twice a day, for the first 21 days. This cycle will repeat every 28 days unless the disease progresses or unacceptable side effects occur. After completing the treatment, patients will be followed up every six months for two years. The study measures the response to treatment by evaluating the reduction in the size of the tumors. A confirmed response is considered when there is at least a 50% decrease in the size of the largest tumors and no new sites of disease. The study also assesses any potential toxicity associated with this treatment.

Official TitlePhase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma
NCT00082888
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

93 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesHodgkin DiseaseImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-CellLymphoma, T-CellLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellDisease AttributesPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Criteria

Inclusion Criteria: * 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 * Mycosis fungoides/ Sezary syndrome * Relapsed Hodgkin's disease (patients must be previously treated and either have had a transplant or not be eligible for a transplant) * Previously treated (no limitations on the number of prior therapies); patients with aggressive lymphoma (Study 1 - permanently closed to accrual 6/28/06) should have received or be ineligible for potentially curable therapy including stem cell transplant * MEASURABLE DISEASE: Must have at least one lesion that has a single diameter of \>= 2 cm or tumor cells in the blood \>= 5 x10\^9/L * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Absolute neutrophil count \>=1000/mm\^3 * Platelet count \>= 75,000 * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 2 x upper limit of normal (ULN) (if \> 2 x ULN direct bilirubin is required and should be =\< 1.5 x ULN) * Aspartate aminotransferase (AST) =\< 3 x ULN (=\< 5 x ULN if liver involvement is present) * Serum creatinine =\< 2 x ULN * Expected survival \>= 3 months * Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent * Capable of swallowing intact study medication tablets * Capable of following directions regarding taking study medication, or has a daily caregiver who will be responsible for administering study medication Exclusion Criteria: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, United StatesOpen University of Iowa/Holden Comprehensive Cancer Center in Google Maps
Suspended

Mayo Clinic

Rochester, United States
Completed2 Study Centers
Assessment of Tipifarnib in Relapsed Non-Hodgkin's Lymphoma | PatLynk