Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years from diagnosis
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My melanoma is at an advanced stage or has come back.
Select...
My bone marrow is working well.
Select...
I was diagnosed at 21 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years from diagnosis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years from diagnosis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreOther outcome measures
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 moreTrial 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
~1930
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,584 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not well-managed with my current medication.I have been hospitalized for depression or other mental health issues.I am using steroids only for adrenal insufficiency, inhalers, or as premedication for transfusions or imaging.My thyroid condition is not well-managed with medication.I have a history of severe heart or blood vessel problems.My melanoma is at an advanced stage or has come back.My liver and kidneys are working well.I do not have any infections that are currently uncontrolled.You are allergic to non-pegylated interferon α-2b.I have been treated with dacarbazine or temozolomide before.I have autoimmune hepatitis.My bone marrow is working well.I was diagnosed at 21 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: Temozolomide/peginterferon alfa-2b
- Group 2: Peginterferon alfa-2b/non-pegylated interferon alfa-2b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide further information regarding previous experiments involving Recombinant interferon alfa-2b?
"The first known trial of recombinant interferon alfa-2b occurred at Marshfield Clinic - Weston Center in 1998, with a total of 476 studies completed to date. Of the ongoing 224 trials, many are happening near Memphis, Tennessee."
Answered by AI
What therapeutic uses has recombinant interferon alfa-2b been demonstrated to confer benefits for?
"Recombinant interferon alfa-2b can be utilized to combat an array of diseases such as anaplastic astrocytoma, anthracycline-based chemotherapy, and acquired immunodeficiency syndrome."
Answered by AI
Is enrollment for this experiment still ongoing?
"At this juncture, the clinical trial is not enrolling volunteers. This scientific experiment was originally posted on October 1st 2007 and updated recently on April 1st 2022. Should you be in pursuit of other studies, 754 different trials are currently admitting patients with melanoma malignant and 224 for Recombinant interferon alfa-2b respectively."
Answered by AI
Has the FDA authorized Recombinant interferon alfa-2b for therapeutic purposes?
"The safety of recombinant interferon alfa-2b was assessed at a 2 on the 1 to 3 scale, as this is currently only in its second phase and has yet to demonstrate efficacy."
Answered by AI
What is the current capacity of this research project?
"Sadly, this clinical trial is no longer enrolling patients. It was posted on October 1st 2007 and then updated most recently April 1st 2022. For those searching for other opportunities, there are currently 754 investigations actively recruiting participants with melanoma malignancy as well as 224 trials that require Recombinant interferon alfa-2b volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger