Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00053781|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : November 9, 2010
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 or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: perifosine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||December 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053781
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Princess Margaret Hospital at University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L-4M1|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Chair:||Donald S. Ernst, MD, FRCPC||London Health Sciences Centre|