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Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
This study is ongoing, but not recruiting participants.
First Received: May 14, 2004   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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: Treatment, Open Label
Official Title: Phase II Evaluation Of FTI (RII5777) In Treatment Of Relapsed And Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response (complete response, unconfirmed complete response, or partial response) during the first 6 courses of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Laboratory measures [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 123
Study Start Date: March 2004
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the tumor response in patients with relapsed or refractory non-Hodgkin's or 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 [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
Investigators
Study Chair: Thomas E. Witzig, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: M. D. Anderson Cancer Center at University of Texas ( Francis J. Giles )
Study ID Numbers: CDR0000360887, MAYO-LS038B, NCI-6246
Study First Received: May 14, 2004
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00082888     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Leukemia, Lymphoid
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Mantle Cell Lymphoma
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Follicular Lymphoma
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Mycoses
Cutaneous T-cell Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Large-cell
Leukemia, B-cell, Chronic
Hodgkin Disease
Lymphoma
Tipifarnib
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Anaplastic Large Cell Lymphoma

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

ClinicalTrials.gov processed this record on September 03, 2009