Status:
COMPLETED
Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors
Lead Sponsor:
NYU Langone Health
Conditions:
Tumors, Central Nervous System
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
This is an open-label, single arm study evaluating a multi-peptide (tumor-associated antigens)/Montanide vaccine in patients \< 21 years of age with recurrent or refractory CNS tumors. The study prima...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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 eligible.
- Patients must be HLA A\*0201 positive.
- Age \< 21 years
- Patients must weigh \> 15kg due to the amount of blood required for immune function studies.
- 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.
- 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
- Life expectancy \> 3 months
- 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)
- Measurable disease is not required.
- Informed consent must be signed by the patient or legal representative.
- Exclusion Criteria
- Serious illness, eg, uncontrolled infections requiring antibiotics.
- History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
- Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination site) or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior the first dose of study agent.
- Pregnant or lactating women are not permitted.
- Women of child-bearing potential not using medically acceptable means of contraception.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00935545
Start Date
July 1 2009
End Date
January 1 2014
Last Update
January 26 2016
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016