NCT00005794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 8, 2003

Completed
Last Updated

December 13, 2019

Status Verified

October 1, 2015

First QC Date

June 2, 2000

Last Update Submit

December 12, 2019

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

perifosineDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Interventions

perifosine

Study Officials

  • Lynn Van Ummersen, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2000

First Posted

October 8, 2003

Study Start

February 1, 2000

Study Completion

July 1, 2003

Last Updated

December 13, 2019

Record last verified: 2015-10

Locations

US(1)