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Perifosine in Treating Patients With Advanced Solid Tumors

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00005794
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
40.9
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.

  • Determine the qualitative and quantitative toxic effects of this drug in these patients.

  • Determine the pharmacokinetics of this drug in these patients.

  • Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.

  • Determine the recommended starting dose for phase II trials on this drug schedule in these patients.

  • Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.

  • Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
Study Start Date :
Feb 1, 2000
Actual Study Completion Date :
Jul 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable

    • Refractory to further treatment with known forms of effective therapy

    • No clinically active CNS metastasis

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • 0-2
    Life expectancy:
    • At least 12 weeks
    Hematopoietic:

    • WBC at least 4,000/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin normal

    • SGOT no greater than 2.5 times upper limit of normal

    Renal:

    • Creatinine normal OR

    • Creatinine clearance at least 60 mL/min

    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception during and for at least 6 months after study participation

    • Maintaining a reasonable state of nutrition consistent with weight maintenance

    • No recent history of weight loss greater than 10% of current body weight

    • No frequent vomiting/poor alimentation

    • No other serious concurrent medical illness that would preclude study therapy

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No concurrent immunotherapy
    Chemotherapy:

    • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered

    • No other concurrent chemotherapy

    Endocrine therapy:

    • No concurrent hormonal therapy

    • Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest

    Radiotherapy:

    • At least 4 weeks since prior radiotherapy

    • No concurrent radiotherapy

    Surgery:

    • See Disease Characteristics

    • At least 21 days since prior major surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6164

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Lynn Van Ummersen, MD, University of Wisconsin, Madison

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT00005794
    Other Study ID Numbers:
    • 1999-355
    • P30CA014520
    • WCCC-CO-99906
    • ASTA-D-21266
    • NCI-T99-0036
    • CDR0000067752
    First Posted:
    Oct 8, 2003
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Oct 1, 2015
    Keywords provided by University of Wisconsin, Madison
    unspecified adult solid tumor, protocol specific

    Study Results

    No Results Posted as of Dec 13, 2019