Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Laboratory Biomarker Analysis
- Conditions
- Anaplastic Large Cell Lymphoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 93
- Locations
- 2
- Primary Endpoint
- Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. To evaluate known and unknown molecular markers that may predict for response to R115777 in lymphoma tissue. OUTLINE: 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.
Investigators
Eligibility 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
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
Arms & Interventions
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.
Intervention: Laboratory Biomarker Analysis
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.
Intervention: Tipifarnib
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival(Up to 2 years)
- Time to Progression(up to 2 years)
- Number of Patients Who Experienced Grade 3 or 4 Toxicities(Up to 56 days)
- Duration of Response(up to 2 years)