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Tipifarnib in Treating Patients With Advanced Hematologic Cancer
This study has been completed.
First Received: July 5, 2000   Last Updated: November 16, 2008   History of Changes
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005967
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer.


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

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Hodgkin's Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma
Drug Information available for: R 115777 Tipifarnib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies

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

Study Start Date: August 2000
Detailed Description:

OBJECTIVES:

  • Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies.
  • Determine the safety profile of this drug in this patient population.
  • 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.

PROJECTED ACCRUAL: A total of 32-36 patients will be accrued for this study within 16 months.

  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%

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

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:

  • See Disease Characteristics
  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • 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
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
University of Chicago
Investigators
Study Chair: Todd M. Zimmerman, MD University of Chicago
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000067950, UCCRC-10294, NCI-42
Study First Received: July 5, 2000
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00005967     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Polycythemia
Chronic Myelomonocytic Leukemia
Blast Crisis
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Follicular Lymphoma
Refractory Anemia
Acute Myelocytic Leukemia
Preleukemia
Anemia, Refractory
Hemorrhagic Disorders
Acute Myeloid Leukemia, Adult
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Myeloproliferative Disorders
Leukemia, Myeloid
Multiple Myeloma
B-cell Lymphomas
Leukemia, Myeloid, Accelerated Phase
Chronic Myelogenous Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid

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

ClinicalTrials.gov processed this record on May 07, 2009