NCT00053781

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have metastatic or recurrent malignant melanoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
4 months until next milestone

Study Start

First participant enrolled

June 20, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2004

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2009

Completed
Last Updated

August 4, 2023

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

February 5, 2003

Last Update Submit

August 3, 2023

Conditions

Melanoma (Skin)

Keywords

recurrent melanomastage IV melanoma

Interventions

perifosineDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Metastatic or recurrent disease deemed incurable by standard therapies * Clinically and/or radiologically documented disease by at least 1 site that is unidimensionally measurable as follows: * At least 20 mm by x-ray or physical exam * At least 10 mm by spiral CT scan * At least 20 mm by non-spiral CT scan * Bone lesions are not considered measurable * Outside previously irradiated area unless evidence of progression or new lesions within irradiated field * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal * Creatinine no greater than ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reactions to compounds of similar chemical or biological composition to perifosine * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No ongoing or active infection * No other concurrent uncontrolled medical illness, psychiatric illness, or social situation that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 months since prior adjuvant immunotherapy * No prior immunotherapy for recurrent/metastatic disease Chemotherapy * No prior chemotherapy (including regional therapy) * No other concurrent cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy) Surgery * At least 4 weeks since prior major surgery Other * No other concurrent anticancer therapy or investigational agents

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

Sponsors & Collaborators

Study Sites (6)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital at University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (1)

  • Ernst DS, Eisenhauer E, Wainman N, Davis M, Lohmann R, Baetz T, Belanger K, Smylie M. Phase II study of perifosine in previously untreated patients with metastatic melanoma. Invest New Drugs. 2005 Dec;23(6):569-75. doi: 10.1007/s10637-005-1157-4.

    PMID: 16034524RESULT

MeSH Terms

Conditions

Melanoma

Interventions

perifosine

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Donald S. Ernst, MD, FRCPC

    London Health Sciences Centre

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

June 20, 2003

Primary Completion

September 14, 2004

Study Completion

December 21, 2009

Last Updated

August 4, 2023

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)