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New combo therapy shows promise for kids with advanced melanoma

NCT ID NCT00539591

Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase II study tested a combination of two drugs—peginterferon alfa-2b and temozolomide—in 29 children with high-risk melanoma that had spread or come back. The main goal was to see how well the tumors shrank and to check for side effects. The study also looked at how long children stayed cancer-free after treatment with peginterferon alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peginterferon alfa-2b and temozolomide
What this could lead to
If successful, this combination could offer a new treatment option for children with advanced melanoma that cannot be removed by surgery.
What could go wrong
This is a small, early-phase study (Phase II) with only 29 participants, so results may not apply to all children. The drugs can cause serious side effects like severe mood changes and organ toxicity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

May 2008

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous melanoma melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malignant melanoma

Contacts and locations

Locations

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Children's Cancer Hospital at UT M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

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