- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005794
Perifosine in Treating Patients With Advanced Solid Tumors
A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
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.
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Lynn Van Ummersen, MD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1999-355
- P30CA014520 (U.S. NIH Grant/Contract)
- WCCC-CO-99906
- ASTA-D-21266
- NCI-T99-0036
- CDR0000067752 (Other Identifier: UWCCC? Unknown)
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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