A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent Malignant Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Donald S. Ernst, MD, FRCPC
Investigator Role:
Study Chair
Investigator Affiliation:
London Regional Cancer Program at London Health Sciences Centre
Authority:
United States: Federal Government
Study ID:
I156
NCT ID:
NCT00053781
Start Date:
June 2003
Completion Date:
December 2009
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|
