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Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
This study has been completed.
Study NCT00053781   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: July 23, 2008   History of Changes

February 5, 2003
July 23, 2008
June 2003
 
 
 
Complete list of historical versions of study NCT00053781 on ClinicalTrials.gov Archive Site
 
 
 
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma

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.

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.

Phase II
Interventional
Treatment, Open Label
Melanoma (Skin)
Drug: perifosine
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00053781
 
CDR0000269475, CAN-NCIC-IND156
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Study Chair: Donald S. Ernst, MD, FRCPC London Regional Cancer Program at London Health Sciences Centre
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP