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

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: Schering-Plough
• Treatments: Antineoplastic Agents; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Temozolomide

Criteria

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.