A Phase I Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide ISA-51VG in Pediatric Patients With Recurrent or Refractory Central Nervous System Tumors
1. Patients with primary central nervous system tumors recurrent or refractory to
standard therapy. Patients with recurrent tumors other than refractory anaplastic
astrocytoma, glioblastoma multiforme or medulloblastoma must have failed all
available second line therapies considered to be standard of care prior to inclusion
in this study.
2. Patients with tumor histologies which have previously been shown to express at least
one of the tumor associated antigens (TRP2, gp100, EphA2 or Her2) are eligible.
Patients whose tumors are shown to express at least one of these antigens are also
3. Patients must be HLA A*0201 positive.
4. Age < 21 years
5. Patients must weigh > 15kg due to the amount of blood required for immune function
6. Lansky performance status or Karnofsky performance status > 50. Patients who are
unable to walk because of paralysis but who are up in a wheelchair, will be
considered ambulatory for the purpose of assessing the performance score.
7. Adequate organ function:
Hematologic: WBC > 1000/mm3 Absolute lymphocyte count > 500 Hemoglobin > 9 gm/dl
(may be transfused to achieve adequate hemoglobin level) Platelet count > 50,000/mm3
INR and PTT < 1.5 x the upper limit of normal
Hepatic: AST/ALT < 2 x the upper limit of institutional normal Total bilirubin < 1.5
x the upper limit of institutional normal
Renal: Serum creatinine < upper limit of normal for the patient's age
8. Life expectancy > 3 months
9. Patients must have fully recovered from previous surgery, chemotherapy, radiotherapy
and biologic therapy. No chemotherapy, radiation therapy or immunotherapy within 4
weeks prior to the first dose of study agent (6 weeks for nitrosureas)
10. Measurable disease is not required.
11. Informed consent must be signed by the patient or legal representative.
1. Serious illness, eg, uncontrolled infections requiring antibiotics.
2. History of immunodeficiency disease (such as HIV) or autoimmune disease except
3. Concomitant treatment with systemic corticosteroids greater than physiologic doses.
Topical (but not at the proposed vaccination site) or inhalational steroids are
4. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior the first dose of study agent.
5. Pregnant or lactating women are not permitted.
6. Women of child-bearing potential not using medically acceptable means of