- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00053781
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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Ontario
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London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital at University Health Network
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Quebec
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Universite de Montreal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Donald S. Ernst, MD, FRCPC, London Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I156
- CAN-NCIC-IND156 (Other Identifier: PDQ)
- CDR0000269475 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma (Skin)
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
Clinical Trials on perifosine
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
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University Health Network, TorontoNational Cancer Institute (NCI)Completed
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Memorial Sloan Kettering Cancer CenterUniversity of Wisconsin, Madison; Duke University; AEterna ZentarisCompleted
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National Cancer Institute (NCI)CompletedLymphoma | Myelodysplastic Syndromes | Leukemia | Unspecified Adult Solid Tumor, Protocol Specific | Myelodysplastic/Myeloproliferative NeoplasmsUnited States
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Dana-Farber Cancer InstituteCompletedWaldenstrom's MacroglobulinemiaUnited States
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Daphne FriedmanKeryx Biopharmaceuticals; Keryx / AOI Pharmaceuticals, Inc.CompletedChronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
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AEterna ZentarisDana-Farber Cancer InstituteCompletedWaldenström's MacroglobulinemiaUnited States