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Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma  Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
For Condition: adult non-Hodgkin's lymphoma,Waldenstrom's Macroglobulinemia,anaplastic large cell lymphoma,Chronic Lymphocytic Leukemia,mycosis fungoides and Sezary syndrome
Status: Recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have relapsed or refractorynon-Hodgkin's lymphoma.
Details: OBJECTIVES: Primary - Determine the tumor response in patients with relapsed or refractory non-Hodgkin's lymphoma treated with tipifarnib. - Determine the toxicity of this drug in these patients. Secondary - Correlate known and unknown molecular markers with response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive vs indolent vs uncommon). Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years. PROJECTED ACCRUAL: A total of 41-123 patients (12-41 with aggressive lymphoma, 17-41 with indolent lymphoma, and 12-41 with uncommon lymphoma) will be accrued for this study within 6-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed non-Hodgkin's lymphoma - Relapsed or refractory disease - The following histologies are eligible: - Aggressive lymphoma - Transformed lymphoma - Diffuse large B-cell lymphoma - Mantle cell lymphoma - Grade 3 follicular lymphoma - Indolent lymphoma - Small lymphocytic lymphoma/chronic lymphocytic leukemia - Grade 1 or 2 follicular lymphoma - Extranodal marginal zone B-cell lymphoma of MALT type - Nodal marginal zone B-cell lymphoma - Splenic marginal zone B-cell lymphoma - Uncommon lymphoma - Unspecified peripheral T-cell lymphoma - Anaplastic large cell lymphoma (T and null cell type) - Lymphoplasmacytic lymphoma - Mycosis fungoides/Sezary syndrome - Patients with aggressive lymphoma must have received or be ineligible for potentially curative therapy, including stem cell transplantation - Measurable disease, defined by 1 of the following: - At least one unidimensional lesion 2 cm in diameter - More than 5,000 tumor cells/mm^3 in the blood - No CNS lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count 1,000/mm^3 - Platelet count 75,000/mm^3 - Hemoglobin 9 g/dL Hepatic - Total bilirubin 2 times upper limit of normal (ULN) OR - Direct bilirubin 1.5 times ULN - AST 3 times ULN (5 times ULN if liver involvement is present) Renal - Creatinine 2 times ULN Other - No other active malignancies - No peripheral neuropathy grade 2 - No serious non-malignant disease that would preclude study participation - No active infection - No known allergy to imidazole drugs - No other life-threatening illness unrelated to tumor - Capable of swallowing intact study medication tablets - Able to follow directions regarding study medications OR has a daily caregiver to administer study medication - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - More than 3 weeks since prior biologic therapy - No concurrent immunologic agents Chemotherapy - More than 3 weeks since prior myelosuppressive or cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - More than 2 weeks since prior corticosteroids for lymphoma - Concurrent stable (not increased within the last month) chronic doses (maximum of 20 mg of prednisone daily) of corticosteroids for disorders other than lymphoma allowed Radiotherapy - More than 3 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent cancer therapy - No other concurrent cytotoxic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, Mayo Clinic Cancer Center
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting George Weiner 319-353-8620
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Witzig 507-284-2511
Additional Information:
Study ID Numbers: CDR0000360887; NCI-6246,MAYO-LS038B
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082888
Other Anaplastic Large Cell Lymphoma Studies:
1. Beta Alethine in Treating Patients With Waldenstrom's Macroglobulinemia
2. Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Waldenstrom's Macroglobulinemia
3. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation
4. Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
5. Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorder
Related Studies:
Other anaplastic large cell lymphoma Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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