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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 Mycosis Fungoides And Sezary Syndrome Studies:
1. Bortezomib and Fludarabine in Treating Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
2. Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas
3. A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)
4. A Pilot Trial of CP-461 in Patients with Chronic Lymphocytic Leukemia
5. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
Related Studies:
Other mycosis fungoides and Sezary syndrome Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
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