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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Soft Tissue Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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External Beam Radiation Therapy (RT)

Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description

Group Type ACTIVE_COMPARATOR

External Beam Radiation Therapy (RT)

Intervention Type PROCEDURE

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.

External Beam RT + DC Injection

Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description

Group Type EXPERIMENTAL

External Beam Radiation Therapy (RT)

Intervention Type PROCEDURE

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

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type PROCEDURE

Autologous Dendritic Cells

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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immunotherapy

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No