NCT00539591Active, not recruitingPhase 2
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 2 Oct 2007
- Start date
- 9 May 2008
- Primary completion date
- 30 Jun 2015
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Melanoma, Childhood cancers
- NCT number
- NCT00539591
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 29
- From 9 May 2008 to the primary completion date, 30 Jun 2015
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Therapy with dacarbazine or temozolomide
- Patients with hypo- or hyperthyroidism not adequately controlled with medication.
Other illness
- 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 a history of myocardial infarction, severe or unstable angina, or severe peripheral vascular disease.
Who the study is looking for
- 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
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Children's Cancer Hospital at UT M.D. Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.