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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

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 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

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

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
442 Previous Clinical Trials
5,308,840 Total Patients Enrolled
5 Trials studying Melanoma
681 Patients Enrolled for Melanoma
Schering-PloughIndustry Sponsor
162 Previous Clinical Trials
41,491 Total Patients Enrolled
11 Trials studying Melanoma
1,428 Patients Enrolled for Melanoma
Alberto Pappo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
608 Total Patients Enrolled
1 Trials studying Melanoma
500 Patients Enrolled for Melanoma

Media Library

Peginterferon alfa-2b (Interferon) Clinical Trial Eligibility Overview. Trial Name: NCT00539591 — Phase 2
Melanoma Research Study Groups: Temozolomide/peginterferon alfa-2b, Peginterferon alfa-2b/non-pegylated interferon alfa-2b
Melanoma Clinical Trial 2023: Peginterferon alfa-2b Highlights & Side Effects. Trial Name: NCT00539591 — Phase 2
Peginterferon alfa-2b (Interferon) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00539591 — Phase 2
~2 spots leftby Sep 2025
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