Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)
This study is currently recruiting participants.
Verified April 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
University of Florida
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01347034
First received: May 2, 2011
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma |
Procedure: Radiotherapy Biological: Autologous Dendritic Cells |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Evaluating Neoadjuvant Administration of High Dose Radiation Therapy and Intratumoral Autologous Dendritic Cells in Patients With High-risk Soft Tissue Sarcomas |
Resource links provided by NLM:
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
- Number of Participants with Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs) [ Time Frame: 11 weeks per participant ] [ Designated as safety issue: No ]Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. The study will require 21 patients in each arm for a total of 42 patients.
Secondary Outcome Measures:
- Number of Participants with Adverse Events [ Time Frame: 11 weeks per participant ] [ Designated as safety issue: Yes ]Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments will be performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention will be paid to DC injection and biopsy related toxicity.
| Estimated Enrollment: | 42 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: External Beam Radiation Therapy (RT)
Arm A - University of Florida - As outlined in Intervention Description
|
Procedure: Radiotherapy
Day 1: Start external beam RT, 25 fractions from days 1-33 administered Monday through Friday only (no conventional external beam RT on days 6, 7, 13, 14, 20, 21, 27, or 28 Days 57-70: Surgery will occur 3-5 weeks after the final dose of external beam RT. Day 78-91: First post-operative visit Days 91-365: Clinical follow-up Beyond day 365, follow-up will be conducted using the standard of care approach applicable to these patients for the determination of disease recurrence, progression and survival. |
|
Experimental: External Beam RT + DC Injection
Arm B - Moffitt Cancer Center - As outlined in Intervention Description
|
Procedure: Radiotherapy
Day 1: Start external beam RT, 25 fractions from days 1-33 administered Monday through Friday only (no conventional external beam RT on days 6, 7, 13, 14, 20, 21, 27, or 28 Days 57-70: Surgery will occur 3-5 weeks after the final dose of external beam RT. Day 78-91: First post-operative visit Days 91-365: Clinical follow-up Beyond day 365, follow-up will be conducted using the standard of care approach applicable to these patients for the determination of disease recurrence, progression and survival. Prior to each injection on Arm B, patients may receive prophylactic doses of a first generation cephalosporin antibiotic per physician discretion. Following each DC injection, Arm B patients will assess procedure-associated pain on a scale of 0-10. The next Monday following each DC injection, the patient will be called and questioned about such procedure associated toxicities. Other Name: immunotherapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Intermediate or High grade (AJCC 7th edition Grade 3 and 4 or Grade 2 and 3 of a 3 tier system) STS as determined by local pathology diagnostic biopsy specimen review
- Musculoskeletal tumor in extremities, trunk or chest wall
- Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1
- Clinical Stage T2N0M0 (AJCC 7th edition)
- Age ≥18 years at time of consent
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1
- Patient's written study specific, Institutional Review Board (IRB) stamped informed consent.
- Adequate organ function (measured within a week prior to beginning treatment for Arm B and within 2 weeks of beginning treatment for Arm A): white blood count (WBC) > 3,000/mm³ and absolute neutrophil count (ANC) >1500/mm³; Platelets > 100,000/mm³; Hematocrit > 25%; Bilirubin < 2.0 mg/dL; Creatinine < 2.0 mg/dL, or creatinine clearance > 60 mL/min
- Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from RT.
Exclusion Criteria:
- Retroperitoneal or Head and Neck primary locations
- Gastrointestinal stromal tumor (GIST)
- Demonstrated metastatic disease
- Contraindication to resection
- Prior RT if the current tumor is locally recurrent after prior resection
- Concurrent treatment with any anticancer agent other than RT as dictated by the protocol
- Prior chemotherapy for the pre-surgical treatment of the primary tumor (neoadjuvant chemotherapy)Bleeding/coagulation disorder
- Human Immunodeficiency Virus (HIV) infection or other primary immunodeficiency disorder
- Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate)
- Steroid therapy within 4 weeks of first DC administration
- Any serious ongoing infection
- Pregnant or lactating women. Patients in reproductive age must agree to use contraceptive methods for the duration of the study (*A pregnancy test will be obtained before treatment).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347034
Locations
| United States, Florida | |
| Shands University of Florida Department of Radiation Oncology | Recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Amanda Prince 904-588-1298 aprince@floridaproton.org | |
| Principal Investigator: Daniel Indelicato, M.D. | |
| Sub-Investigator: Paul Okunieff, M.D. | |
| Sub-Investigator: Mark Scarborough, M.D. | |
| Sub-Investigator: John Reith, M.D. | |
| Sub-Investigator: Robert Zlotecki, M.D. | |
| Sub-Investigator: Charles Gibbs, M.D. | |
| Shands Jacksonville Department of Radiation Oncology | Recruiting |
| Jacksonville, Florida, United States, 32206 | |
| Contact: Amanda Prince, RN, BSN 904-588-1298 aprince@floridaproton.org | |
| Principal Investigator: Daniel Indelicato, M.D. | |
| Sub-Investigator: Robert Marcus, Jr., M.D. | |
| Sub-Investigator: Nancy Mendenhall, M.D. | |
| Sub-Investigator: B. Hudson Berrey, M.D. | |
| H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Courtney Yates 813-745-3620 courtney.yates@moffitt.org | |
| Principal Investigator: Alberto Chiappori, M.D. | |
| Sub-Investigator: Scott Antonia, M.D., Ph.D. | |
| Sub-Investigator: Marilyn Bui, M.D., Ph.D. | |
| Sub-Investigator: David Cheong, M.D. | |
| Sub-Investigator: Dmitry Gabrilovich, M.D., Ph.D. | |
| Sub-Investigator: Ricardo Gonzalez, M.D. | |
| Sub-Investigator: Gang Han, Ph.D. | |
| Sub-Investigator: Randy Heysek, M.D. | |
| Sub-Investigator: William Janssen, Ph.D. | |
| Sub-Investigator: Robert Lavey, M.D. | |
| Sub-Investigator: G. Douglas Letson, M.D. | |
| Sub-Investigator: Damon Reed, M.D. | |
| Sub-Investigator: Jonathan Zager, M.D. | |
| Sub-Investigator: Vernon Sondak, M.D. | |
| Sub-Investigator: Andrea Shaffer, ARNP | |
| Sub-Investigator: Dawn Kettner, PA-C | |
| Sub-Investigator: David E. Jones, Jr., M.D., Ph.D. | |
| Sub-Investigator: David Johnson, PA-C | |
| Sub-Investigator: Anthony Conley, M.D. | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
University of Florida
Investigators
| Principal Investigator: | Alberto Chiappori, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
| Principal Investigator: | Daniel Indelicato, M.D. | University of Florida, Shands Jacksonville |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01347034 History of Changes |
| Other Study ID Numbers: | MCC-16441 |
| Study First Received: | May 2, 2011 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
radiation neoadjuvant intratumoral autologous dendritic cells |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013