Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas
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|ClinicalTrials.gov Identifier: NCT02343224|
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : January 18, 2020
This is a phase II study of the drug, pegylated interferon alfa-2b (PEG-Intron), used to treat brain tumors in a pediatric population. Researchers want to see if treatment with PEG-Intron will stop tumor growth for patients with juvenile pilocytic astrocytomas or optic pathway gliomas.
The purposes of this study are:
- To learn more about the response to pegylated interferon
- To learn more about the side effects of pegylated interferon
- To learn more about MRI images in patients with Juvenile Pilocytic Astrocytomas or Optic Pathway Gliomas.
- To learn more about quality of life in patients treated with pegylated interferon
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Pilocytic Astrocytomas Optic Pathway Gliomas||Drug: Pegylated interferon alpha-2b||Phase 2|
Low grade gliomas are the most common pediatric central nervous system malignancies and can occur in different parts of the brain. Patients who undergo gross total resection, usually those with hemispheric tumors, have an excellent prognosis with surgical resection alone. Patients for whom gross total resection is not achievable have a significant risk of disease progression. Therefore, these patients benefit from adjuvant therapy. Multiple chemotherapy regimens have shown some efficacy in residual tumor, but more than 50% of patients experience recurrences. Radiation has been shown to be an effective therapy in the treatment of these tumors. Because of concerns regarding radiation toxicity especially in young children, and progression despite chemotherapy, novel approaches are needed. This protocol represents an attempt to measure the efficacy and safety of use of pegylated interferon for patients with recurrent, refractory Juvenile Pilocytic Astrocytomas (JPA) or optic pathway gliomas. It provides a different approach to the commonly used treatment modalities. The objectives of this study are to determine the response of children with chemotherapy-refractory progressive JPA or optic pathway gliomas (OPG) to weekly pegylated interferon alpha-2b. The secondary objectives include to better identify the toxicities of weekly pegylated interferon alpha-2b (PEG-Intron™) in pediatric patients with unresectable, refractory, recurrent JPAs or optic pathway gliomas, to evaluate various magnetic resonance imaging techniques for noninvasive monitoring of metabolic and biologic changes in the tumors and to evaluate the quality of life for patients with recurrent, refractory JPAs who receive therapy with pegylated interferon alpha-2b (PEG-Intron™).
The primary end point is to determine the response rate. A two-stage design has been selected to evaluate the response rate. If the treatment demonstrates at least a 25% response rate, the researchers would consider it a promising regimen for further study. A response rate less than 5% is considered evidence of unpromising regimen. Seventeen evaluable pediatric patients with JPA or OPG will be accrued. If at least 3 responders are seen among the 17 patients, this will be considered evidence of a promising response rate for further evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of Pegylated Interferon ALFA-2b in Children With Recurrent or Refractory and Radiographically or Clinically Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Pegylated interferon alpha-2b
Subjects will receive PEG-Intron based on their weight (1 mcg/kg/dose) once a week
Drug: Pegylated interferon alpha-2b
PEG-Intron 1mcg/kg/dose weekly through an injection under the skin on the same day each week
Other Name: Peg-Intron
- Change in response rate of subjects to Peg-Intron from baseline to 2 years [ Time Frame: Baseline, 2 years ]The response rate will be calculated as the ratio of the number of patients who demonstrate response (complete or partial) divided by the number of patients evaluable for response by comparing baseline scans to the scan demonstrating best response. All patients eligible for study who receive Peg-Intron will be considered evaluable for response.
- Event Free Survival [ Time Frame: 2 years ]Event free survival will be based on the standard two or three-dimensional tumor measurements for children with recurrent, refractory or progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas who receive Peg-Intron
- Change in toxicity, collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 of the National Cancer Institute (NCI) [ Time Frame: Baseline, 2 years ]To evaluate hematologic toxicity of long term Peg-Intron administration, adverse event data will be collected using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 of the National Cancer Institute (NCI). CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. Grade 3 or greater hematologic toxicities will be recorded per reporting period.
- Change in Quality of Life, assessed by using the Functional Assessment of Cancer Therapy-Brain (Peds-FACT-Br) questionnaire [ Time Frame: Baseline, 2 years ]Quality of life is assessed by using the Functional Assessment of Cancer Therapy-Brain (Peds-FACT-Br) questionnaire for patients with brain cancer. The FACT-Br instrument consists of 54 items to assess physical(PWB), social and family (SWB), emotional (EWB), functional well-being (FWB), and additional brain cancer specific concerns (AC). Using a 5-point Likert type scale, responses to individual items range from 0 (not at all) to 4 (Very Much) with higher scores indicating better quality of life. PWB, SWB, and FWB are the sum of 7 items and have a possible range between 0 and 28. EWB ranges between 0 and 24, and is the sum of 6 items. AC is the sum of 19 items, and ranges between 0 and 76.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343224
|Contact: Amanda Sanders||404-785-0305||Amanda.Sanders2@choa.org|
|United States, Georgia|
|Children's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator: Dolly Aguilera, MD|
|Principal Investigator:||Dolly Aguilera, MD||Children's Healthcare of Atlanta/Emory University|