Clinical trial NCT00053781: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Halifax
country: Canada
facility: Nova Scotia Cancer Centre
state: Nova Scotia
city: London
country: Canada
facility: Cancer Care Ontario-London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital at University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: London Health Sciences Centre
name: Donald S. Ernst, MD, FRCPC
role: STUDY_CHAIR
References:
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.