Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01241162 |
Recruitment Status :
Completed
First Posted : November 16, 2010
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
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Neuroblastoma Ewings Sarcoma Osteogenic Sarcoma Rhabdomyosarcoma Synovial Sarcoma | Biological: Autologous dendritic cell vaccine with adjuvant | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma. |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
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Experimental: Single arm study
Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant
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Biological: 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 Other Names:
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- Tolerance of study treatment [ Time Frame: 2 years ]Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.
- Tumor Response [ Time Frame: 2 years ]Assessment of tumor responses--complete or partial remission, stable disease, and disease progression--by CT/PET/MIBG or MRI after cycles 2 and 4.
- Immune Response [ Time Frame: 2 years ]Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays.

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Ages Eligible for Study: | 1 Year to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241162
United States, Kentucky | |
University of Louisville, Kosair Charities Pediatric Clinical Research Unit | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Kenneth G Lucas, MD | University of Louisville, Kosairs Charities Pediatric Clinical Research Unit |
Responsible Party: | University of Louisville |
ClinicalTrials.gov Identifier: | NCT01241162 |
Other Study ID Numbers: |
34183 |
First Posted: | November 16, 2010 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | May 2017 |
Neuroblastoma Ewings sarcoma osteogenic sarcoma rhabdomyosarcoma |
synovial sarcoma high-risk relapsed children |
Sarcoma Neuroblastoma Rhabdomyosarcoma Sarcoma, Ewing Sarcoma, Synovial Osteosarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |