A Vaccine Study for High Risk Cancers

NCT00944580 | Withdrawn Phase 1 DMC

• 2 other identifiers: IRB 30761PSHCI 09-033
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and immunological effects of a vaccine for people diagnosed with high risk neuroblastoma, osteogenic sarcoma, and rhabdomyosarcoma. It is hypothesized that this vaccine could reduce the incidence of relapse.

Conditions

Neuroblastoma; Rhabdomyosarcoma; Osteogenic Sarcoma

Keywords

MAGE-A1; MAGE-A3; NY-ESO-1; antigen; vaccine; dendritic cells; immunohistochemistry; immunology

Outcome Measures

Primary Outcomes (1)

• The primary objective is to determine if there is an amplification or new development of NY-ESO-1, MAGE-A1, or MAGE-A3 specific CD4+ or CD8+ T cells post-vaccination.

  2 years

Secondary Outcomes (1)

• The investigators will determine the safety of vaccine and imiquimod administration in these patients.

  2 years

Study Arms (1)

Vaccine Intervention

EXPERIMENTAL

MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine: A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.

Biological: MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine

Interventions

MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine BIOLOGICAL

A regimen of three vaccines every two weeks. Each vaccine will contain 3,000,000-5,000,000 peptide pulsed dendritic cells. Imiquimod, a topical cream, will be applied to the vaccination site before and after each vaccination.

Vaccine Intervention

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 1 to 70 years of age with neuroblastoma, rhabdomyosarcoma, or osteogenic sarcoma, who have one or more of the following high risk features:
• Neuroblastoma:
• Stage IV disease
• Stage III disease with n-myc amplification
• Osteogenic sarcoma:
• Presence of metastases
• Elevated alkaline phosphatase or LDH at diagnosis
• Primary tumor affecting the axial skeleton
• Poor histopathological response after completion of pre-surgical chemotherapy (≥10% viable tumor)
• Rhabdomyosarcoma:
• Stage IV disease
• Alveolar histology
• Positive tumor margins, with lymph node positivity
• Patient meets all screening criteria and tumor is positive for NY-ESO-1, MAGE- A1, or MAGE-A3 by immunohistochemistry or RT-PCR.
• Patients who are between 3 months and 2 years following the completion of therapy, and have achieved at least a very good partial response to primary therapy.

Sponsors & Collaborators

• Penn State University: lead

MeSH Terms

Conditions

Neuroblastoma; Rhabdomyosarcoma; Osteosarcoma

Interventions

MAGEA1 protein, human; MAGEA3 protein, human

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Officials

• Kenneth G. Lucas, MD

  Milton S. Hershey Medical Center

  STUDY CHAIR

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 21, 2009
• First Posted: July 23, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 24, 2017

Record last verified: 2017-11