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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Louisville
Sponsor:
Collaborator:
Solving Kids’ Cancer
Information provided by (Responsible Party):
Kenneth Lucas, University of Louisville
ClinicalTrials.gov Identifier:
NCT01241162
First received: November 15, 2010
Last updated: December 20, 2013
Last verified: December 2013

November 15, 2010
December 20, 2013
August 2010
August 2014   (final data collection date for primary outcome measure)
Tolerance of study treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Tolerance to DAC, at at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles.
Toleration of treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To evaluate the tolerability of DAC and IFN-γ when used with a DC/CT antigen vaccine in patients with relapsed stage IV neuroblastoma.
Complete list of historical versions of study NCT01241162 on ClinicalTrials.gov Archive Site
  • Tumor Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassays.
Measurements of Immune Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Decitabine Followed by a Cancer Antigen Vaccine for Patients With Neuroblastoma and Sarcoma
A Phase I Trial Combining Decitabine and Vaccine Therapy for Patients With Relapsed Neuroblastoma and Sarcoma.

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.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neuroblastoma
  • Ewings Sarcoma
  • Osteogenic Sarcoma
  • Rhabdomyosarcoma
  • Synovial Sarcoma
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)

Imiquimod applied topically to vaccine site before and after vaccination

Other Names:
  • Decitabine (trade name Dacogen or 5-aza-2'-deoxycytidine/DAC
  • Imiquimod (trade name Aladara)
Experimental: Single arm study
Biological/Vaccine: Autologous dendritic cell vaccine with adjuvant
Intervention: Biological: Autologous dendritic cell vaccine with adjuvant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
August 2014
August 2014   (final data collection date for primary outcome measure)

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 - < 18 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, imiquimod, or any vaccine component.
Both
1 Year to 17 Years
No
Contact: Kenneth G Lucas, MD 502-582-0043 k0luca01@louisville.edu
Contact: Deepa Kolaseri, Ph.D 502-582-2447 d.kolaserikrishnadas@louisville.edu
United States
 
NCT01241162
34183
Yes
Kenneth Lucas, University of Louisville
University of Louisville
Solving Kids’ Cancer
Principal Investigator: Kenneth G Lucas, MD University of Louisville, Kosairs Children Charities Pediatric Clinical Research Unit
University of Louisville
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP