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Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
This study has been completed.
Sponsor:
University of Louisville
Collaborator:
Solving Kids’ Cancer
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01241162
First received: November 15, 2010
Last updated: May 8, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Neuroblastoma Ewings Sarcoma Osteogenic Sarcoma Rhabdomyosarcoma Synovial Sarcoma | Biological: Autologous dendritic cell vaccine with adjuvant | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma. |
Resource links provided by NLM:
Drug Information available for:
Decitabine
Genetic and Rare Diseases Information Center resources:
Soft Tissue Sarcoma
Osteosarcoma
Ewing Sarcoma
Ewing's Family of Tumors
Neuroblastoma
Synovial Sarcoma
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by University of Louisville:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 19 |
| Study Start Date: | August 2010 |
| Study Completion Date: | October 2016 |
| Primary Completion Date: | October 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single arm study
Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant
|
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:
|
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.
Eligibility| Ages Eligible for Study: | 1 Year to 24 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241162
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241162
Locations
| United States, Kentucky | |
| University of Louisville, Kosair Charities Pediatric Clinical Research Unit | |
| Louisville, Kentucky, United States, 40202 | |
Sponsors and Collaborators
University of Louisville
Solving Kids’ Cancer
Investigators
| Principal Investigator: | Kenneth G Lucas, MD | University of Louisville, Kosairs Charities Pediatric Clinical Research Unit |
More Information
| Responsible Party: | University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01241162 History of Changes |
| Other Study ID Numbers: |
34183 |
| Study First Received: | November 15, 2010 |
| Last Updated: | May 8, 2017 |
Keywords provided by University of Louisville:
|
Neuroblastoma Ewings sarcoma osteogenic sarcoma rhabdomyosarcoma |
synovial sarcoma high-risk relapsed children |
Additional relevant MeSH terms:
|
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 Vaccines Poly ICLC Decitabine Azacitidine Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 22, 2017