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

NCT00935545 | Completed Phase 1 DMC

• 1 other identifier: 08-1017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumors, Central Nervous System

Keywords

Brain Tumors; High Grade; CNS

Outcome Measures

Primary Outcomes (1)

• 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.

  2-4 weeks

Secondary Outcomes (1)

• 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.

  2-4 weeks

Study Arms (1)

Open Label

EXPERIMENTAL

Biological: Montanide

Interventions

Montanide BIOLOGICAL

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

Open Label

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms

Interventions

Monatide (IMS 3015)

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Sharon Gardner, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 26, 2016

Record last verified: 2016-01

Locations

US (1)