Tipifarnib in Treating Patients With Advanced Hematologic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005967
First received: July 5, 2000
Last updated: February 8, 2013
Last verified: October 2004
  Purpose

Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Drug: tipifarnib
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:


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

Enrollment: 36
Study Start Date: August 2000
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
Drug: tipifarnib

Detailed Description:

OBJECTIVES:

I. Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies.

II. Determine the safety profile of this drug in this patient population. III. Determine the clinical activity of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels.

Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists

    • Hodgkin's or non-Hodgkin's lymphoma

      • Known bone marrow involvement
    • Acute myeloid leukemia
    • Chronic myelogenous leukemia

      • Chronic phase

        • No significant symptoms after treatment
        • No features of accelerated phase or blastic phase
      • Accelerated phase

        • WBC difficult to control with conventional busulfan or hydroxyurea in terms of dose requirement or shortening of intervals between courses
        • Rapid doubling of WBC (less than 5 days)
        • At least 10% blasts in blood or marrow
        • At least 20% blasts plus promyelocytes in blood or marrow
        • At least 20% basophils plus eosinophils in blood
        • Anemia or thrombocytopenia unresponsive to busulfan or hydroxyurea
        • Persistent thrombocytosis
        • Additional chromosome changes
        • Increasing splenomegaly
        • Development of chloromas or myelofibrosis
      • Blastic phase

        • At least 30% blasts plus promyelocytes in blood or bone marrow
    • Acute lymphoblastic leukemia
    • Chronic lymphocytic leukemia
    • Myelodysplastic syndromes

      • Refractory anemia with excess blasts (RAEB)
      • Chronic myelomonocytic leukemia
      • RAEB in transformation
    • Multiple myeloma
    • Chronic myeloproliferative diseases including, but not limited to, myelofibrosis with myeloid metaplasia
  • Measurable or evaluable disease documented by radiographic, hematologic, bone marrow, or clinical examination parameters
  • Refusal of allogeneic bone marrow transplantation allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Albumin at least 2.5 g/dL

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • No other uncontrolled medical disorder
  • No active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • At least 3 days since prior hydroxyurea

Endocrine therapy:

  • At least 4 weeks since prior systemic steroids for multiple myeloma

Radiotherapy:

  • At least 4 weeks since prior radiotherapy

Surgery:

  • No prior total gastrectomy or total ileocolectomy

Other:

  • No prior tipifarnib
  • No concurrent proton pump inhibitors (e.g., omeprazole)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005967

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Investigators
Study Chair: Todd M. Zimmerman, MD University of Chicago
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005967     History of Changes
Other Study ID Numbers: NCI-2012-02342, UCCRC-10294, NCI-42, CDR0000067950
Study First Received: July 5, 2000
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma
Leukemia
Syndrome
Myeloproliferative Disorders
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphatic Diseases
Disease
Pathologic Processes
Tipifarnib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014