Clinical trial · Interventional
Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma
NCT00539591CI-TRIAL-00115826active not recruitingPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peginterferon alfa-2b | Drug | Peginterferon Alfa-2b | ALIAS |
| Recombinant interferon alfa-2b | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Temozolomide/peginterferon alfa-2b
- description
- 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 (SQ) in combination with temozolomide 75mg/m2/dose by mouth (PO) 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.
- interventionNames
- Drug: Peginterferon alfa-2b
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Peginterferon alfa-2b/non-pegylated interferon alfa-2b
- description
- Stratum A: Resected Stages IIC, IIIA, and IIIB patients will receive recombinant interferon alfa-2b 20 million units/m2/day intravenously (IV) 5 consecutive days per week for 4 weeks followed by peginterferon alfa-2b 1mcg/kg subcutaneously (SQ) once a week for 48 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.