Tipifarnib in Treating Patients With Advanced Hematologic Cancer

February 8, 2013 updated by: National Cancer Institute (NCI)

A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Todd M. Zimmerman, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02342
  • UCCRC-10294
  • NCI-42
  • CDR0000067950 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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