Melanoma Clinical Trial
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
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.
This study is for children with malignant melanoma and high risk features (at high risk of melanoma returning or spreading to other parts of the body) or who have recurrent disease. The study has two treatment groups based on the stage of the disease. Patients with stage IIC, IIIA or IIIB melanoma whose tumors have been removed by surgery will be treated in study group A. These patients will receive 4 weeks of high dose interferon alfa-2b followed by 48 weeks of peginterferon. Patients with stage IIIC or IV melanoma, stage III melanoma that could not be removed by surgery and those with recurrent disease will be treated in study group B. These patients will receive peginterferon alfa-2b and temozolomide.
Stratum A: Resected Stages IIC, IIIA, and IIIB patients
Induction therapy (weeks 1-4): Subjects will receive recombinant interferon alfa-2b 20 million units/m2 per day intravenously over 20-30 minutes on 5 consecutive days per week for 4 weeks. Subjects will receive peginterferon alfa-2b 1 mcg/kg/week subcutaneously for a total of 48 weeks.
Stratum B: Resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent patients
Stratum B is divided into 2 groups based on the presence (Stratum B1) or absence (Stratum B2) of measurable disease. Subjects will receive 8 weekly doses of peginterferon alfa-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75mg/m2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course will be 8 weeks. Strata B2 (no measurable disease) will proceed with 7 courses as outlined.
Surgery interventions -Associated with both Strata A and B Surgery description: All subjects with initial presentation of melanoma (T1-4) will be treated with primary wide local excision with a minimum of 1cm margin (if anatomically feasible) surrounding the primary lesion or biopsy scar. For lesions with Breslow's thickness of > 1mm or
Additional objectives include:
To assess the safety of temozolomide administered in combination with peginterferon α-2b to pediatric patients with resected AJCC Stage IIIC, unresectable Stage III, metastatic, or recurrent cutaneous melanoma (Stratum B).
To study the feasibility and safety of administering peginterferon α-2b weekly for 48 weeks following an initial induction phase with intravenous high dose interferon α-2b for 4 weeks to pediatric patients with resected thick melanomas (> 4mm) with ulcerations (AJCC Stage IIC) and resected melanomas with regional lymph node metastases (AJCC Stage IIIA and IIIB) (Stratum A).
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
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.
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There are 3 Locations for this study
San Diego California, 92123, United States
Memphis Tennessee, 38105, United States
Houston Texas, 77030, United States
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