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Interferon

Temozolomide + Peginterferon for Melanoma

Phase 2

Waitlist Available

Led By Alberto Pappo, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AJCC stage IIC, III, IV or recurrent cutaneous melanoma

Adequate bone marrow function

Must not have

Patients with diabetes mellitus not adequately controlled with medication

Patients who have a history of depression or other psychiatric diseases requiring hospitalization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from diagnosis

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well temozolomide and peginterferon alfa-2b work in treating patients with unresectable Stage III, metastatic, or recurrent cutaneous melanoma.

Who is the study for?

This trial is for children up to 21 years old with high-risk melanoma that can't be removed by surgery or has spread. They must have good liver, kidney, and bone marrow function and no history of severe depression, uncontrolled infections, certain heart diseases, poorly controlled diabetes or thyroid conditions. Prior treatment with dacarbazine or temozolomide disqualifies them.

What is being tested?

The study tests the effectiveness of combining two drugs: Temozolomide and Peginterferon alfa-2b in treating pediatric patients with advanced melanoma. The aim is to see how well tumors respond to this combination therapy.

What are the potential side effects?

Possible side effects include allergic reactions to the medications used, issues affecting blood cells leading to increased infection risk or bleeding problems, fatigue, mood changes like depression due to interferon use, as well as potential liver and kidney function impairment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma is at an advanced stage or has come back.

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My bone marrow is working well.

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I was diagnosed at 21 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes is not well-managed with my current medication.

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I have been hospitalized for depression or other mental health issues.

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My thyroid condition is not well-managed with medication.

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I have a history of severe heart or blood vessel problems.

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I do not have any infections that are currently uncontrolled.

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I have been treated with dacarbazine or temozolomide before.

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I have autoimmune hepatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from diagnosis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from diagnosis

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from diagnosis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Strata B1 and B2

Number of Patients Who Experience Toxicity at or Above the Target Toxicity for Stratum A Patients

Probability of Event-free Survival (EFS) of Stratum A Participants

+1 more

Other study objectives

Apparent Clearance (CL) of Pegylated Interferon ɑ-2B

Area Under the Curve (AUC) of Interferon ɑ-2b

Area Under the Curve (AUC) of Pegylated Interferon ɑ-2B

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Temozolomide/peginterferon alfa-2bExperimental Treatment2 Interventions

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.

Group II: Peginterferon alfa-2b/non-pegylated interferon alfa-2bExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peginterferon alfa-2b

2001

Completed Phase 3

~2250

Temozolomide

2010

Completed Phase 3

~1880