A Phase 1 interventional study of Montanide in Tumors, Central Nervous System, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2016-01-26.
Sponsored by NYU Langone Health · Phase 1, Interventional, and Treatment
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.
673 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.
This study's enrollment of 15 is below the median of 35 across 464 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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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
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.
Also known as: Montanide ISA-51 VG
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.
Time frame: 2-4 weeks
Evaluate cellular immune responses induced in pts after injection of TAA mixed with Montanide and document tumor response in pts w/ measurable disease or time to progression in pts without measurable disease following injection of TAA mixed w/ Montanide.
Time frame: 2-4 weeks
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Central Nervous System Neoplasms→
NYU Langone Health