Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
18 Years
N/A
Both
Intraocular Melanoma, Melanoma (Skin)
Trial Information
Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
OBJECTIVES:
- Determine the response rate in patients with recurrent or metastatic malignant melanoma
treated with PEG-interferon alfa-2b and thalidomide.
- Determine the quantitative and qualitative toxic effects of this regimen in these
patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral
thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months
in the absence of disease progression or unacceptable toxicity. Patients achieving a
complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond
documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma, including any of the following:
- Cutaneous melanoma
- Ocular melanoma
- Mucosal melanoma
- Unidentified primary tumor
- Recurrent or metastatic disease
- Bidimensionally measurable or evaluable disease
- Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior
radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT ≤ 2 times ULN
Renal
- Creatinine ≤ 2 mg/dL
Cardiovascular
- None of the following conditions within the past 3 months:
- Congestive heart failure
- Second- or third-degree heart block
- Myocardial infarction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception (1 highly effective
and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after
completion of study treatment
- No other malignancy within the past 2 years except adequately treated skin cancer or
carcinoma in situ of the cervix
- No concurrent blood, sperm, or ova donation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy (e.g., interferon) allowed
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
Surgery
- At least 28 days since prior surgery
Other
- No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate as measured scans and tumor measurements every 8 weeks
Safety Issue:
No
Principal Investigator
Ulka N. Vaishampayan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000445593
NCT ID:
NCT00238329
Start Date:
January 2001
Completion Date:
June 2007
Related Keywords:
- Intraocular Melanoma
- Melanoma (Skin)
- recurrent melanoma
- stage IV melanoma
- ciliary body and choroid melanoma, medium/large size
- extraocular extension melanoma
- iris melanoma
- recurrent intraocular melanoma
- Melanoma
- Uveal Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
