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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343224
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
CURE Childhood Cancer, Inc.
Information provided by (Responsible Party):
Dolly Aguilera, Emory University

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

Condition or disease Intervention/treatment Phase
Juvenile Pilocytic Astrocytomas Optic Pathway Gliomas Drug: Pegylated interferon alpha-2b Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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
  • Must not have received growth factor within 2 weeks of entry into this study
  • Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior enrollment in the study
  • Adequate organ, hematological, renal, and pulmonary function
  • If history of depression or psychiatric illness, has to be well controlled with antidepressants and/or under psychiatrist/psychologist care

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Amanda Sanders 404-785-0305 Amanda.Sanders2@choa.org

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Dolly Aguilera, MD         
Sponsors and Collaborators
Emory University
CURE Childhood Cancer, Inc.
Investigators
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Principal Investigator: Dolly Aguilera, MD Children's Healthcare of Atlanta/Emory University
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Responsible Party: Dolly Aguilera, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02343224    
Other Study ID Numbers: IRB00074563
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Astrocytoma
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Eye Diseases
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs