Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma

NCT ID: NCT01241162

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2016-10-31

Brief Summary

This treatment study for relapsed high-risk neuroblastoma, Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma or synovial sarcoma involves an autologous cancer testis (CT) antigen specific dendritic cell (DC) vaccine preceded by decitabine as a demethylating chemotherapy.

Detailed Description

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Conditions

Neuroblastoma; Ewings Sarcoma; Osteogenic Sarcoma; Rhabdomyosarcoma; Synovial Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm study

Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant

Group Type: EXPERIMENTAL

Autologous dendritic cell vaccine with adjuvant

Intervention Type: BIOLOGICAL

Week 1:

Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri)

Weeks 2 and 3:

Vaccine: 3-5 E6 peptide pulsed DC (Mon)

Hiltonol applied topically to vaccine site before and after vaccination

Interventions

Autologous dendritic cell vaccine with adjuvant

Week 1:

Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri)

Weeks 2 and 3:

Vaccine: 3-5 E6 peptide pulsed DC (Mon)

Hiltonol applied topically to vaccine site before and after vaccination

Intervention Type: BIOLOGICAL

Other Intervention Names

Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC; Hiltonol

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of relapsed high-risk neuroblastoma,Ewings sarcoma, osteogenic sarcoma, rhabdomyosarcoma, synovial sarcoma
• Patient may have gross tumor that has been treated with multi-agent chemotherapy prior study entry, but does not need to have gross tumor prior to study entry.
• Patients must have had a diagnosis of neuroblastoma or sarcoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
• Have received standard chemotherapy and/or SCT, and are at least 6 months post-transplant.
• Age: Patients must be 1 - < 25 years of age when registered on study.
• Organ Function Requirements: All patients must have adequate organ function defined as:
• Hematological Function: ANC ≥ 500; Platelet count ≥ 75.
• Renal Function: Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR A maximum serum creatinine (mg/dL) based on age/gender as follows: 1YO M&F = 0.6, 2-5YO M&F = 0.8, 6-9YO M&F = 1, 10-12YO M&F = 1.2, 13-15YO M = 1.5, 13-15YO F = 1.4, 16+ M = 1.7, 16+ F = 1.4
• Cardiac Function: Patient must have normal cardiac function documented by Ejection fraction (> 55%) documented by echocardiogram or radionuclide MUGA evaluation OR Fractional shortening (≥ 28%) documented by echocardiogram
• Liver Function: Total bilirubin ≤ 1.5 x normal for age, AND SGPT (ALT) and SGOT (AST) ≤ 3 x normal for age.
• Room air pulse oximetry >94%.
• Male and female sexually active patients of reproductive age who wish to participate must agree to use acceptable contraception.
• Lansky performance scale > 70, ECOG < 2 (Appendix I).

Exclusion Criteria

• Patient is pregnant.
• Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
• Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
• Patient is receiving concurrent systemic steroid therapy.
• Patient has a known systemic hypersensitivity to DAC, Hiltonol, or any vaccine component.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Solving Kids' Cancer

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth G Lucas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, Kosairs Charities Pediatric Clinical Research Unit

Locations

University of Louisville, Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

34183

Identifier Type: -

Identifier Source: org_study_id