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Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
perifosine
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Center - Calgary
  • Nova Scotia Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Princess Margaret Hospital at University Health Network
  • Centre Hospitalier de l'Universite de Montreal
  • McGill University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053781
Brief Title
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Official Title
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2003 (Actual)
Primary Completion Date
September 14, 2004 (Actual)
Study Completion Date
December 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma. Assess the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses after documentation of CR or stable PR (i.e., no further tumor shrinkage). Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
perifosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald S. Ernst, MD, FRCPC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital at University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L-4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16034524
Citation
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.
Results Reference
result

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Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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