Phase 2 N=20 Treatment

Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)

Soft Tissue Sarcoma

Bottom Line

View on ClinicalTrials.gov: NCT01347034 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Aug 2014

Primary outcome: Primary: Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs) — 2; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: External Beam Radiation Therapy (RT) (Procedure); Autologous Dendritic Cells (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)	2; 5	—
SECONDARY Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)	0; 0; 6; 14	—

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.

Eligibility 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 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01347034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.