Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Me… (NCT00539591) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
United States29 participantsStarted 2008-05-09
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tumor Response Rate
Timeframe: 8 weeks
2
Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2
Timeframe: 52 weeks
3
Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients
Timeframe: 52 weeks
4
Probability of Event-free Survival (EFS) of Stratum A Participants