Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053781
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : November 9, 2010
National Cancer Institute (NCI)
Information provided by:
Canadian Cancer Trials Group

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: perifosine Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
Study Start Date : June 2003
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN


  • Creatinine no greater than ULN


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • 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


Biologic therapy

  • At least 3 months since prior adjuvant immunotherapy
  • No prior immunotherapy for recurrent/metastatic disease


  • No prior chemotherapy (including regional therapy)
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy)


  • At least 4 weeks since prior major surgery


  • No other concurrent anticancer therapy or investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053781

Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital at University Health Network
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Study Chair: Donald S. Ernst, MD, FRCPC London Health Sciences Centre

Publications of Results: Identifier: NCT00053781     History of Changes
Other Study ID Numbers: I156
CDR0000269475 ( Other Identifier: PDQ )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas