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A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Children With Newly Diagnosed Malignant or Intrinsic Brain Stem Gliomas (BSG) or Non-Brainstem High-Grade Gliomas (HGG) or Recurrent Unresectable Low-Grade Gliomas (LGG) or Recurrent High Grade Gliomas


N/A
12 Months
21 Years
Open (Enrolling)
Both
Newly Diagnosed Pediatric Pontine Glioma., Newly Diagnosed Pediatric High Grade Glioma., Recurrent Pediatric High Grade Glioma., Recurrent Pediatric Low Grade Glioma.

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Trial Information

A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Children With Newly Diagnosed Malignant or Intrinsic Brain Stem Gliomas (BSG) or Non-Brainstem High-Grade Gliomas (HGG) or Recurrent Unresectable Low-Grade Gliomas (LGG) or Recurrent High Grade Gliomas

Inclusion Criteria


Eligibility Criteria

*Tumor Types - Tumor type/location:

Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven
high-grade glioma* involving the brainstem. Patients may not have received chemotherapy
during or after radiation. Patients must be registered within 4-12 weeks of completing
radiation.

Stratum B: Newly diagnosed, non-brainstem high-grade glioma* Patients may not have
received chemotherapy during or after radiation. Patients must be registered within 4-12
weeks of completing radiation.

Stratum C: Unresectable low-grade gliomas that have received at least two
chemotherapy/biologic regimens. Patients may not have received radiation to the index
lesion within 1 year of enrollment.

Stratum D: Non-brainstem high-grade gliomas* that have recurred following treatment.

Stratum E: Newly diagnosed high-grade gliomas* or brain stem gliomas who received
chemotherapy during radiation therapy. Patients may not have received chemotherapy after
radiation therapy was completed. Patients must be registered within 4-12 weeks of
completing radiation.

Stratum F: Newly diagnosed high-grade gliomas with metastatic disease within the CNS
requiring craniospinal radiation therapy. Patients may or may not have received
chemotherapy during radiation, but cannot have received chemotherapy after radiation
therapy was completed. Patients must be registered within 4-12 weeks of completing
radiation.

- Eligible histologies include glioblastoma (GBM), anaplastic astrocytoma (AA) or
gliosarcoma. Patients with any oligodendroglioma component are NOT eligible.

- HLA-A2 positive based on flow cytometry.

- Patients in Stratum A B and E must have received standard involved field radiation
therapy [RT] defined as fractionated external beam radiotherapy with total doses
between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks
of completing RT.

- Patients in Stratum F must have received craniospinal radiation.

- Patients must be clinically stable and off or on low-dose (no more than 0.1
mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to
study registration.

- All patients must sign an IRB-approved informed consent document

- Patients must be ≥ 12 months and <22 years of age at the time of study registration.

- Patients must have a performance status of ≥ to 60; (Karnofsky if > 16 years and
Lansky if ≤ 16 years of age.

- Patients must have life expectancy of at least 8 weeks.

- documented negative serum βHCG for female patients who are post-menarchal. Because
the effect of the peptide-based vaccine and poly-ICLC on the fetus has not
sufficiently been investigated, pregnant females will not be included in the study.
Males and females must agree to use effective birth control methods during the course
of vaccination (from the first vaccine to two weeks after the last vaccine). Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately. Because there is an unknown
but potential risk for adverse events in nursing infants secondary to treatment of
the mother with the peptide-based vaccine and poly-ICLC, breastfeeding should be
discontinued if the mother is treated in this study.

- Patients must be free of systemic infection at the time of registration. Patients on
IV antibiotic therapy must be off IV antibiotics for at least 7 days prior to
registration.

- Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µl;
Platelets > 100,000/µl (transfusion independent); absolute lymphocyte count of
≥500/uL; Hemoglobin >8 g/dl (may be transfused). Hepatic: bilirubin ≤ 1.5x
institutional normal for age; SGPT (ALT) < 3x institutional normal.

Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR >70
ml/min/ml/min/1.73 m²

- Patients on Strata C and D must have recovered from the toxic effects of prior
therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or
myelosuppressive biological therapy and at least 1 week from the last dose of
non-myelosuppressive biologic therapy. Any questions related to the definition of
non-cytotoxic agents should be directed to the Principal Investigator.

- No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

- Exclusion Criteria

3.2.1 Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with
low grade gliomas (stratum C) may have tumor spread within the CNS. Patients in Stratum F
must have tumor spread within the CNS.

3.2.2 Patients enrolled in Strata A and B may not have received any prior chemotherapy or
anti-glioma therapy of any type other than radiation therapy (see 3.1.3) Patients
enrolled on stratum C must have received at least two prior chemotherapy or biologic
therapy regimens and may not have received radiation to the index lesion within 1 year of
enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after
radiation therapy was completed.

3.2.3 Concurrent treatment or medications (must be off for at least 1 week) including:

- Interferon (e.g. Intron-A®)

- Allergy desensitization injections

- Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)

- Interleukins (e.g. Proleukin®)

- Any investigational therapeutic medication

3.2.4 Patients must not have a history of, or currently active autoimmune disorders
requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral
involvement.

3.2.5 Use of immunosuppressives within four weeks prior to study entry or anticipated use
of immunosuppressive agents. Dexamethasone, or other corticosteroid medications, if used
in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1
mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration.
Topical corticosteroids are acceptable.

3.2.6 Patients with known addiction to alcohol or illicit drugs.

3.2.7 Because patients with immune deficiency are not expected to respond to this therapy,
HIV-positive patients are excluded from the study.

3.3 Start of Treatment

3.3.1 Patients must be registered prior to the start of treatment.

3.3.2 The date protocol therapy is projected to start must be no later than 7 days after
the date of study registration.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

The incidence and severity of adverse events associated with the vaccine regimen

Safety Issue:

Yes

Principal Investigator

Regina Jakacki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital of Pittsburgh of UPMC

Authority:

United States: Food and Drug Administration

Study ID:

PRO08030085

NCT ID:

NCT01130077

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Newly Diagnosed Pediatric Pontine Glioma.
  • Newly Diagnosed Pediatric High Grade Glioma.
  • Recurrent Pediatric High Grade Glioma.
  • Recurrent Pediatric Low Grade Glioma.
  • Pediatric glioma
  • Vaccine therapy
  • Glioma
  • Pontine Glioma

Name

Location

Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213