A Vaccine Study for High Risk Cancers - Full Text View

Sponsor:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00944580

Purpose

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.

Condition	Intervention	Phase
Neuroblastoma Rhabdomyosarcoma Osteogenic Sarcoma	Biological: MAGE-A1, MAGE-A3, and NY-ESO-1 Vaccine	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Study to Determine the Immunologic Effects of a MAGE- A1, MAGE- A3, NY-ESO-1 Vaccine in Patients With High Risk Neuroblastoma, Osteogenic Sarcoma, and Rhabdomyosarcoma

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

MedlinePlus related topics: Cancer Neuroblastoma Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The investigators will determine the safety of vaccine and imiquimod administration in these patients. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	June 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Detailed Description:

MAGE -A1, MAGE- A3, and NY-ESO-1 are antigens that can be found with significant frequency on neuroblastoma, rhabdomyosarcoma, and osteogenic sarcoma, three relatively common solid tumors that in some cases can be associated with a high risk for relapse. In this study each subject will be screened for the presence of these antigens, and an individualized vaccine will be developed and administered using the subject's own dendritic cells (DC).

This study consists of two phases: a screening phase and a treatment/vaccine phase. First, eligible individuals will be consented into the screening phase. Tumor specimens will be tested by immunohistochemistry or RT-PCR for the presence of MAGE- A1, MAGE- A3, and NY-ESO-1. Those testing positive for one or more antigen can be consented for the treatment phase of the study. Blood will be drawn for DC culture, and approximately one month later a series of three vaccines will be administered at two week intervals. Subjects will receive a topical medication called imiquimod to the vaccine site prior to and following each injection, to help immune cells travel into the area. Study participation occurs over 18 months and also involves periodic physical examinations and blood draws.

Eligibility

Ages Eligible for Study:	1 Year to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for Screening Phase:

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

Inclusion Criteria for Vaccine Phase:

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.
No chemotherapy is planned for one month following the last vaccination.
Bilirubin <2 mg/dL, and SGOT/SGPT <2.5 x normal
Creatinine clearance > 50ml/min as estimated by patient's serum creatinine, weight, and age
Room air pulse oximetry >94%
Patient is not pregnant
Male and female sexually active patients of reproductive who wish to participate must agree to use acceptable contraception
Patient is not moribund and has a projected life expectancy >6 months
Lansky performance scale > 70, ECOG < 2 (Appendix I)
Potential subjects will be tested for HIV 1 and 2 antibodies, HTLV 1/2 antibodies, and for HIV 1, hepatitis C and hepatitis B virus by NAT testing. - -Subjects testing positive for any of these pathogens will be ineligible for vaccine.
White blood cells ≥ 2.5 K/µL, Hemoglobin ≥ 8 g/dL, Hematocrit > 25%, and Platelets ≥ 70 K/µL
Patient does not have central nervous system involvement.
Patient does not a have a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis
Patient is not receiving concurrent systemic steroid therapy
Patient does not have a known systemic hypersensitivity to imiquimod or any vaccine component

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944580

Sponsors and Collaborators

Penn State University

Investigators

Study Chair:

Kenneth G. Lucas, MD

Penn State-Hershey

More Information

No publications provided

Responsible Party:	Kenneth G. Lucas, MD, Penn State University
ClinicalTrials.gov Identifier:	NCT00944580 History of Changes
Other Study ID Numbers:	IRB 30761, PSHCI 09-033
Study First Received:	July 21, 2009
Last Updated:	July 26, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

MAGE-A1
MAGE-A3
NY-ESO-1
antigen

vaccine
dendritic cells
immunohistochemistry
immunology

Additional relevant MeSH terms:

Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Sarcoma
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
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Myosarcoma
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on February 09, 2012