Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well tipifarnib works in treating patients with relapsed or refractory lymphoma.

Further Study Information

OBJECTIVES:

Primary

• Proportion of confirmed response.

Secondary

• Overall Survival

• Time to Progression

• Duration of Response

• Toxicity

OUTLINE: This is a multicenter study. Patients are stratified according to histology (aggressive [closed to accrual as of 6/28/2006] vs indolent [closed to accrual as of 9/26/2007] 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 until disease progression and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 41-123 patients (12-41 with aggressive lymphoma [closed to accrual as of 6/28/2006], 17-41 with indolent lymphoma [closed to accrual as of 9/26/2007], and 12-41 with uncommon lymphoma) will be accrued for this study within 6-24 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-Hodgkin's or Hodgkin's lymphoma

• Relapsed or refractory disease

• The following histologies are eligible:

• Aggressive lymphoma (closed to accrual as of 6/28/2006)

• Transformed lymphoma

• Diffuse large B-cell lymphoma

• Mantle cell lymphoma

• Grade 3 follicular lymphoma

• Indolent lymphoma (closed to accrual as of 9/26/2007)

• 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

• Hodgkin's lymphoma

• Patients with aggressive lymphoma (closed to accrual as of 6/28/2006) OR Hodgkin's 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

• At least 3 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent cancer therapy

• No other concurrent cytotoxic agents

Trial Contact Information

Trial Lead Organizations/Sponsors

Mayo Clinic Cancer Center

Thomas E. Witzig

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00082888
Information obtained from ClinicalTrials.gov on December 15, 2011

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