Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

NCT02343224 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00074563
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Juvenile Pilocytic Astrocytomas; Optic Pathway Gliomas

Outcome Measures

Primary Outcomes (1)

• Number of Children Responding to Treatment

  The objective response of study participants was categorized as complete response, partial response, or stable disease. Determination of tumor response or progression is based on the pre-study baseline scan performed closest to time of study entry. The overall response assessment takes into account response in both target and non-target lesion, and the appearance of new lesions. Complete response is defined as the disappearance of all target lesions and non-target lesions, and no new lesions. Partial response is defined as ≥ 65% decrease in the sum of the products of the three perpendicular diameters of all target lesions, and no development of new lesions. Stable disease is defined as neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for partial response, nor sufficient increase in a single target lesion to qualify for progressive disease, as well as no new lesions.

  Month 12

Secondary Outcomes (2)

• Number of Participants Meeting Event Free Survival Criteria

  Month 12, Month 24

• Number of Participants Meeting Overall Survival Criteria

  Month 12, Month 24

Study Arms (1)

Pegylated interferon alpha-2b

EXPERIMENTAL

Subjects will receive PEG-Intron based on their weight (1 mcg/kg/dose) once a week

Drug: Pegylated interferon alpha-2b

Interventions

Pegylated interferon alpha-2b DRUG

PEG-Intron 1mcg/kg/dose weekly through an injection under the skin on the same day each week

Also known as: Peg-Intron

Pegylated interferon alpha-2b

Eligibility Criteria

• Age: 3 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be older than 3 years and less than or equal to 25 years of age at the time of enrollment
• Patients with neurofibromatosis are eligible
• Histologic confirmation is not required for this if the patient has neurofibromatosis type 1 (NF-1) with MRI findings consistent with optic pathway glioma or JPA. Any other tumors will need histological confirmation, either at the time of diagnosis or at the time of recurrence. The histological diagnosis includes World Health Organization (WHO) grade I JPA
• Patients must have measurable residual disease, defined as tumor that is measurable in two or three perpendicular diameters on MRI. For a lesion to be considered measurable, it must be at least twice the slice thickness on MRI (i.e visible on more than one slice)
• All patients must have a brain MRI with and without contrast (gadolinium) within 30 days prior to study enrollment. All patients with history of spinal or leptomeningeal disease and those patients with symptoms suspicious of spinal disease, must have a spine MRI with contrast (gadolinium) performed within 30 days prior to study enrollment. Lumbar puncture is necessary if there is evidence of tumor dissemination on the MRI of spine
• Performance Level: Karnofsky \> or equal to 50% for patients \> 10 years of age or Lansky \> or equal to 50 for patients \< 10 years of age
• Patients must have recovered (to Common Toxicity Criteria (CTC) v.5.0 ≤ Grade 1 unless indicated below) from the acute toxic effects of all prior chemotherapy, immunotherapy prior to entering this study, with the exception of alopecia, weight changes and Grade I or II lymphopenia
• Must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
• At least 7 days must have elapsed since the completion of therapy with other biologic agents. For other biologic agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• At least 3 half-lives of the antibody after the last dose of a monoclonal antibody. Specifically for bevacizumab 36 days after the last dose
• At least 3 weeks from the last surgical resection, prior to start study drug
• At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
• Patients must have had their last fraction of cranial or craniospinal Radiation ≥ 24 months prior to study entry
• Patients who have received polyinosinic-polycytidylic acid-polylysine-carboxymethylcellulose (Poly-ICLC) are eligible for this trial if all acute Poly-ICLC -related toxicity has resolved
• Patients must not have received Pegylated interferon previously

You may not qualify if:

• Patients who are receiving concurrent chemotherapy, or who are currently receiving other investigational chemotherapeutic agents or concurrently receiving radiation
• Patients with a known hypersensitivity to interferon-alpha
• Prior use of Pegylated interferon or interferon
• Less than 2 years since completion of radiation therapy
• Pregnant or breast-feeding females are excluded
• Patients with clinically significant unrelated systemic illness
• Dental braces or prosthesis that interferes with magnetic resonance (MR) imaging
• History of noncompliance to medical regimens
• Patients unwilling to or unable to comply with the protocol
• Patients with a positive history of Hepatitis B or Hepatitis C
• Male patient whose sexual partner(s) are women of childbearing potential who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
• Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period
• Patient with diagnosis of Diffuse Intrinsic Pontine Glioma

Sponsors & Collaborators

• Emory University: lead
• CURE Childhood Cancer, Inc.: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Astrocytoma

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Dolly Aguilera MD
• Organization: Emory University

Dolly.Aguilera@choa.org

404-785-3515

Study Officials

• Dolly Aguilera, MD

  Children's Healthcare of Atlanta/Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 21, 2015
• Study Start: November 1, 2014
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: January 24, 2022
• Results First Posted: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)