Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | December 2009 |
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 |
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| 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 | |
| Study Chair: | Donald S. Ernst, MD, FRCPC | London Regional Cancer Program at London Health Sciences Centre |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00053781 History of Changes |
| Other Study ID Numbers: | I156, CAN-NCIC-IND156, CDR0000269475 |
| Study First Received: | February 5, 2003 |
| Last Updated: | November 7, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by NCIC Clinical Trials Group:
|
recurrent melanoma stage IV melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 23, 2013