Temozolomide + Peginterferon for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic corticosteroids, including oral steroids like prednisone and dexamethasone, as well as topical steroid creams or ointments. However, steroid inhalers, steroid replacement for adrenal insufficiency, and steroid premedication for allergic reactions are allowed.
What data supports the effectiveness of the drug Temozolomide + Peginterferon for treating melanoma?
Research shows that combining Temozolomide with interferon alpha-2b, including its pegylated form, may increase the effectiveness against melanoma, as both components are active in treating this condition. Studies have indicated improved response rates when these drugs are used together compared to using them alone.12345
Is the combination of Temozolomide and Peginterferon safe for humans?
How is the drug Temozolomide + Peginterferon different from other melanoma treatments?
What is the purpose of this trial?
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.
Research Team
Alberto S. Pappo
Principal Investigator
St. Jude Children's Research Hospital
Eligibility Criteria
This trial is for children up to 21 years old with high-risk melanoma that can't be removed by surgery or has spread. They must have good liver, kidney, and bone marrow function and no history of severe depression, uncontrolled infections, certain heart diseases, poorly controlled diabetes or thyroid conditions. Prior treatment with dacarbazine or temozolomide disqualifies them.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy (Stratum A)
Subjects 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.
Maintenance Therapy (Stratum A)
Subjects receive peginterferon alfa-2b 1 mcg/kg/week subcutaneously for a total of 48 weeks.
Treatment Course (Stratum B)
Subjects 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 a 2-week break.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
Treatment Details
Interventions
- Peginterferon alfa-2b
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Schering-Plough
Industry Sponsor
Fred Hassan
Schering-Plough
Chief Executive Officer since 2003
PhD in Organic Chemistry from Harvard University
Dr. Robert J. Spiegel
Schering-Plough
Chief Medical Officer since 2006
MD from the University of Pennsylvania