Perifosine in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005794
First received: June 2, 2000
Last updated: July 23, 2008
Last verified: December 2003
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: perifosine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer

Resource links provided by NLM:


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

Study Start Date: February 2000
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.

  Eligibility

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

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
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: NCT00005794

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: Lynn Van Ummersen, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005794     History of Changes
Other Study ID Numbers: CDR0000067752, WCCC-CO-99906, ASTA-D-21266, NCI-T99-0036
Study First Received: June 2, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 18, 2014