Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

MEL06

The main goal of this study is to estimate the tumor response rate of temozolomide administered in combination with peginterferon alfa-2b to pediatric patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.

2008-05-09

2015-06-01

2026-05-01

Active (not recruiting)

Early phase I

29

Inclusion Criteria: * AJCC stage IIC, III, IV or recurrent cutaneous melanoma * Adequate bone marrow function * Age less than or equal to 21 years of age at diagnosis * Adequate liver and kidney function Exclusion Criteria: * Prior Therapy with dacarbazine or temozolomide * Patients who have uncontrolled infection * Patients with autoimmune hepatitis * Patients who have a history of depression or other psychiatric diseases requiring hospitalization * Patients taking systemic corticosteroids including oral steroids (i.e. prednisone, dexamethasone) or topical steroid creams/ointments. Steroid containing inhalers, steroid replacement for adrenal insufficiency and steroid premedication for prevention of transfusion or imaging contrast-agent related allergic reaction will be permitted. * Patients with hypersensitivity reaction to non-pegylated interferon α-2b are not eligible for study * Patients with diabetes mellitus not adequately controlled with medication * Patients with hypo- or hyperthyroidism not adequately controlled with medication. * Patients with a history of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ACTUAL'}}

2023-09-08