PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma

Eastern Cooperative Oncology Group

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Treatments

Biological: PEG-interferon alfa-2b

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00049530

E2602 (Other Identifier)

CDR0000258114

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Peginterferon (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.

Full description

OBJECTIVES:

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.

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 disease progression, patients then discontinue treatment. If there is no disease progression, 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
- Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry
Age: 18 and over
ECOG Performance status of 0-2
Life expectancy 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)
Alanine Aminotransferase (ALT) no greater than 2 times ULN
Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
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
Negative pregnancy test
Fertile patients must use effective contraception

Exclusion criteria

Myocardial infarction within the past 6 months
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
Other concurrent illness that would preclude study participation
History of severe depression
Pregnant or nursing