Overview

This trial is active, not recruiting.

Condition soft tissue sarcoma
Treatments external beam radiation therapy (rt), autologous dendritic cells
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator University of Florida
Start date January 2011
End date August 2013
Trial size 20 participants
Trial identifier NCT01347034, MCC-16441

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
external beam radiation therapy (rt)
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)
Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
external beam radiation therapy (rt)
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.
autologous dendritic cells immunotherapy
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)
time frame: 11 weeks per participant

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Alberto Chiappori, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.