Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00082888

Run by

National Cancer Institute (NCI)

People needed

93

Starts

2004-03-24

Expected to finish

2017-07-05

Last updated by the study team

2020-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

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

Where it is running

• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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