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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-IND156 | Other Identifier | PDQ | |
| CDR0000269475 | Other Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perifosine | Drug |
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:
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Donald S. Ernst, MD, FRCPC | London Health Sciences Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Baker Cancer Center - Calgary | Calgary | Alberta | T2N 4N2 | Canada | ||
| Nova Scotia Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16034524 | Result | 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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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C105905 | perifosine |
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| Halifax |
| Nova Scotia |
| B3H 1V7 |
| Canada |
| Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Princess Margaret Hospital at University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2L-4M1 | Canada |
| McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |