Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma

Overview

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.

Full Title of Study: “A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 14, 2004

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.

Interventions

  • Drug: perifosine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NCIC Clinical Trials Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Donald S. Ernst, MD, FRCPC, Study Chair, London Health Sciences Centre

Citations Reporting on Results

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.

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