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Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors

Primary Purpose

Tumors, Central Nervous System

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Montanide

About this trial

This is an interventional treatment trial for Tumors, Central Nervous System focused on measuring Brain Tumors, High Grade, CNS

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

NYU Langone Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00935545

First Posted

July 7, 2009

Last Updated

January 25, 2016

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT00935545

Brief Title

Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tumors, Central Nervous System

Keywords

Brain Tumors, High Grade, CNS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open Label

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Montanide

Other Intervention Name(s)

Montanide ISA-51 VG

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

2-4 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sharon Gardner, MD

Organizational Affiliation

NYU Langone Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Study of Peptide Vaccination With Tumor Associated Antigens Mixed With Montanide in Patients With CNS Tumors

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