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A Phase II Study of Pegylated Interferon Alfa-2b (Peg-Intron (TM)) in Children With Diffuse Pontine Gliomas


Phase 2
N/A
21 Years
Not Enrolling
Both
Diffuse Intrinsic Pontine Glioma

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Trial Information

A Phase II Study of Pegylated Interferon Alfa-2b (Peg-Intron (TM)) in Children With Diffuse Pontine Gliomas


Background:

Children with diffuse pontine gliomas have a dismal prognosis. Because surgery in this area
is difficult, radiation therapy has been the mainstay of treatment. Although some children
may improve clinically after radiation therapy, the effect is short-lived and almost all
progress within several months. Chemotherapy has not had a significant impact on survival.
Interferon-alpha is a cytokine that has been studied in patients with gliomas and has
demonstrated some activity in prior clinical trials.

Objectives:

- To compare the 2-year survival of pediatric patients with diffuse pontine gliomas
receiving weekly subcutaneous low-dose pegylated interferon alfa-2b (PEG-Intron[TM])
injections after standard radiation therapy versus historical controls who have
received radiation therapy alone.

- To define the toxicities of weekly low-dose pegylated interferon alfa-2b
(PEG-Intron(Trademark)) in pediatric patients.

Eligibility:

Age: Patients must be less than or equal to 21 years of age.

Histological Diagnosis: Histologic confirmation is not required for this study. Patients
must have a diffuse pontine glioma as diagnosed by MRI criteria below.

Radiologic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter
presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal
abnormality involving at least 50 percent of the pons.

Prior Therapy: The patient must have received adequate radiation therapy. Radiation must
be completed between 2-10 weeks prior to the start of treatment with Peg-Intron[TM].

Design:

In this study, we plan to administer pegylated interferon alfa-2b (PEG-Intron[TM])
subcutaneously once a week to pediatric patients with diffuse pontine gliomas who have
completed radiation therapy. The endpoint of the trial will be 2-year survival compared to
historical controls.

Inclusion Criteria


- INCLUSION CRITERIA:

Age: Patients must be less than or equal to 21 years of age.

Histological diagnosis: Histologic confirmation is not required for this study. Patients
must have a diffuse pontine glioma as diagnosed by magnetic resonance imaging (MRI)
criteria below.

Radiographic Appearance: Patients must have a diffuse intrinsic tumor with the epicenter
presumed to be in the pons. The T-2 weighted sequence must reveal a diffuse signal
abnormality involving at least 50 percent of the pons.

Prior therapy: The patient must have received adequate radiation therapy. (Radiation must
be completed between 2-10 weeks prior to the start of treatment with Peg-Intron (TM).

Performance status: Patients should have an Cooperative Oncology Group (ECOG) performance
status of 0, 1, 2, or 3 (see below). Patients who are unable to walk because of paralysis,
but who are up in a wheel chair will be considered ambulatory for the purpose of
calculating the performance score.

ECOG Performance Status:

Score--Clinical Status

0--Asymptomatic

1. -Symptomatic, fully ambulatory

2. -Symptomatic, in bed less than 50 percent of the day

3. -Symptomatic, in bed greater than 50 percent of the day but not bedridden

4. -Bedridden

Hematological function: Patients must have adequate bone marrow function defined as a
peripheral absolute granulocyte count of greater than 1000/mm^3, hemoglobin greater
than 8 gm/dL, and platelet count greater than 100,000/mm^3. Patients may be
transfused with red blood cells (RBC's) or platelets to achieve these parameters.

Hepatic function: Patients must have adequate liver function, defined as total
bilirubin less than 2.5 times the upper limit of normal, direct bilirubin within
normal limits, and serum glutamic pyruvic transaminase (SGPT) less than 2.0 times the
upper limit of normal. Patients with Gilbert Syndrome are excluded from both the
total and direct bilirubin requirements. (Gilbert Syndrome is found in 3-10 percent
of the general population and is characterized by mild, chronic hyperbilirubinemia in
the absence of liver disease or overt hemolysis.)

Renal function: Patients must have an age-adjusted normal serum creatinine (see
below) OR a creatinine clearance greater than or equal to 60 mL/min/1.73 m^2.

Age (Years)---Maximum Serum Creatinine (mg/dl)

less than or equal to 5---0.8

greater than 5 and less than or equal to 10---1.0

greater than 10 less than or equal to 15---1.2

greater than 15---1.5

Steroids: Patients on steroids must be on a stable or decreasing dose of steroids for
greater than or equal to 1 week prior to study entry.

Informed consent: All patients or their legal guardians (if the patient is less than
18 years old) or DPA must sign a document of informed consent indicating their
understanding of the investigational nature and the risks of this study. When
appropriate, pediatric patients will be included in all discussions in order to
obtain verbal assent.

Durable Power of Attorney (DPA): Assignment of DPA to a family member or guardian
should be offered to all patients 18 to 21 years of age.

EXCLUSION CRITERIA:

Patients with known or suspected neurofibromatosis-1

Patients who have received prior chemotherapy, including radiosensitizers, or who are
currently receiving other investigational chemotherapeutic agents

Patients with a known hypersensitivity to interferon-alpha

Pregnant or breast-feeding females are excluded because the effects of pegylated
interferon alfa-2b (PEG-Intron (TM)) on the unborn fetus are unknown.

Patients with clinically significant unrelated systemic illness (including autoimmune
disease, serious infections or significant cardiac, pulmonary, hepatic or other organ
dysfunction) which in the judgment of the Principal or Associate Investigators would
compromise the patient's ability to tolerate this therapy or are likely to interfere
with the study procedures or results.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas

Outcome Description:

Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.

Outcome Time Frame:

8 yrs 6 mo 0 days

Safety Issue:

No

Principal Investigator

Kathy Warren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

020193

NCT ID:

NCT00036569

Start Date:

May 2002

Completion Date:

January 2012

Related Keywords:

  • Diffuse Intrinsic Pontine Glioma
  • Brainstem Glioma
  • Pediatric
  • Interferon
  • MR Imaging
  • Angiogenesis
  • Brain Tumor
  • Glioma
  • Pediatric Brain Tumor
  • Glioma
  • Pontine Glioma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892