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| Sponsor: | New York University School of Medicine |
|---|---|
| Information provided by (Responsible Party): | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00935545 |
Purpose
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 primarily evaluates the safety of this regimen. Secondarily, immunogenicity and anti-tumor effects will be assessed.
The primary aim is to evaluate the safety of subcutaneous injections of tumor associated antigens (TAA) mixed with Montanide ISA-51VG in patients with recurrent or refractory brain tumors.
The secondary aims are to evaluate cellular immune responses induced in patients after subcutaneous injection of TAA mixed with Montanide ISA-51VG and to document tumor response in patients with measurable disease or time to progression in patients without measurable disease following subcutaneous injection of TAA mixed with Montanide ISA-51VG.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors, Central Nervous System |
Biological: Montanide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 14 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open Label |
Biological: Montanide
Montanide is an oil-based immunoadjuvant similar to Incomplete Freund´s Adjuvant, which is commonly used in combination with peptide vaccines. Although its precise mode of action is not known, it acts to enhance the immune response to vaccination. It has a depot effect that depending on the type of emulsion will release the antigen slowly from the injection site.
Other Name: Montanide ISA-51 VG
|
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
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
Exclusion Criteria
Contacts and Locations| United States, New York | |
| NYU Langone Medical Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Sharon Gardner, MD | NYU Langone Medical Center |
More Information
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00935545 History of Changes |
| Other Study ID Numbers: | 08-1017 |
| Study First Received: | July 7, 2009 |
| Last Updated: | March 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Brain Tumors High Grade CNS |
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Nervous System Diseases |