Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI MAYO-LS038B 6246, NCI-6246, NCT00082888

Special Category: SPORE trial

Objectives

Primary

1. Determine the tumor response in patients with relapsed or refractory non-Hodgkin's or Hodgkin's lymphoma treated with tipifarnib.
2. Determine the toxicity of this drug in these patients.

Secondary

1. Correlate known and unknown molecular markers with response in patients treated with this drug.

Entry 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/mm³ in the blood



• No CNS lymphoma

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 75,000/mm³
• 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

Expected Enrollment

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.

Outcomes

Confirmed response (complete response, unconfirmed complete response, or partial response) during the first 6 courses of treatment

Overall survival
Progression-free survival
Duration of response
Laboratory measures
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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Thomas Witzig, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

U.S.A.
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623

Registry Information
Official Title		Phase II Evaluation Of FTI (RII5777) In Treatment Of Relapsed And Refractory Lymphoma
Trial Start Date		2004-03-24
Trial Completion Date		2006-10-02 (estimated)
Registered in ClinicalTrials.gov		NCT00082888
Date Submitted to PDQ		2004-03-04
Information Last Verified		2008-03-30
NCI Grant/Contract Number		CA97274, CA15083

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