Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma - Full Text View

Sponsor:	NCIC Clinical Trials Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00053781

Purpose

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	Intervention	Phase
Melanoma (Skin)	Drug: perifosine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Perifosine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

June 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053781

Locations

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)

Investigators

Study Chair:

Donald S. Ernst, MD, FRCPC

London Regional Cancer Program at London Health Sciences Centre

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000269475, CAN-NCIC-IND156
Study First Received:	February 5, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00053781 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on November 27, 2009