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Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma

NCT00539591 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-23

Study results available
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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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

Peginterferon alfa-2b

Given either IV or SQ. Therapeutic drug class: interferon.

DRUG

Temozolomide

Given PO. Therapeutic drug class: antineoplastic agent.

DRUG

Recombinant interferon alfa-2b

Given IV. Therapeutic drug classes: antineoplastic agent, immunomodulatory agent, interferon

Sponsors & Collaborators

Principal Investigators

  • Alberto Pappo, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-09
Primary Completion
2015-06-30
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00539591 on ClinicalTrials.gov