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Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
This study is ongoing, but not recruiting participants.

First Received on May 14, 2004.   Last Updated on November 2, 2011   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by (Responsible Party): Mayo Clinic
ClinicalTrials.gov Identifier: NCT00082888
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
 Drug: Tipifarnib
 Phase II

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Farnesyltransferase Inhibitor Tipifarnib (RII5777) In Treatment Of Relapsed And Refractory Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia Lymphoma
Drug Information available for: R 115777 Tipifarnib
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Proportion of 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Overall survival time was defined as the time from registration to the date of death or last follow-up.

  • Time to Progression [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation.

  • Duration of Response [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.

  • Toxicity [ Time Frame: 3/26/2004 - 2/1/2011 ] [ Designated as safety issue: Yes ]
    Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0


Enrollment: 93
Study Start Date: March 2004
Estimated Study Completion Date: January 2012
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: R115777 (Tipifarnib) Drug: Tipifarnib
cycle 1 = 300 mg BID. After cycle 1 patients may increase the dose to 400mg b.i.d. or 600mg b.i.d. at physician discretion p.o. days 1-21 q 28 days.

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082888

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas E. Witzig, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Witzig TE, Tang H, Micallef IN, Ansell SM, Link BK, Inwards DJ, Porrata LF, Johnston PB, Colgan JP, Markovic SN, Nowakowski GS, Thompson CA, Allmer C, Maurer MJ, Gupta M, Weiner G, Hohl R, Kurtin PJ, Ding H, Loegering D, Schneider P, Peterson K, Habermann TM, Kaufmann SH. Multi-institutional phase 2 study of the farnesyltransferase inhibitor tipifarnib (R115777) in patients with relapsed and refractory lymphomas. Blood. 2011 Nov 3;118(18):4882-9. Epub 2011 Jul 1.

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00082888     History of Changes
Other Study ID Numbers: CDR0000360887, P50CA097274, P30CA015083, LS038B, 6246
Study First Received: May 14, 2004
Results First Received: November 2, 2011
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
recurrent adult diffuse large cell lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent mycosis fungoides/Sezary syndrome
refractory chronic lymphocytic leukemia
anaplastic large cell lymphoma
Waldenstrom macroglobulinemia
 recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Leukemia
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012



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