|Phase II||Treatment||Closed||18 and over||NCI, Other||CDR0000258114|
ECOG-2602, E2602, NCT00049530
RATIONALE: PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.
Further Study Information
- Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma over-expressing b-FGF.
- Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.
- Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
- Induction: Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is no disease progression, patients then proceed to maintenance.
- Maintenance: Patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.
- Histologically confirmed stage IV melanoma
- Stage M1a, M1b, or M1c
- Mucosal, ocular, or unknown primary melanoma
- Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- Plasma basic fibroblast growth factor level at least 15 pg/mL
- Measurable or evaluable disease
- CNS involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
- Brain CT scan or MRI to confirm stable disease required ≤ 4 weeks prior to study entry
- 18 and over
- ECOG 0-2
- At least 6 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL (transfusions allowed)
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- ALT no greater than 2 times ULN
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- No myocardial infarction within the past 6 months
- No other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No other concurrent illness that would preclude study participation
- No history of severe depression
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior interferon in the adjuvant or metastatic setting
- At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting
- At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting
- At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting
- At least 4 weeks since prior surgery in the adjuvant or metastatic setting
- At least 4 weeks since other prior therapy in the adjuvant or metastatic setting
Trial Lead Organizations/Sponsors
Eastern Cooperative Oncology GroupNational Cancer Institute
|Ronald S. Go||Study Chair|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00049530
ClinicalTrials.gov processed this data on October 17, 2013
Back to Top