External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma

Completed · Phase 2

Conditions studied: Soft Tissue Sarcoma

In brief

This is a Phase II study using a combination of external beam radiation with intratumoral injection of dendritic cells (white blood cells) as neo-adjuvant treatment for patients with high-risk soft tissue sarcoma. The purpose was to determine if an injection of the patient's own immune related white blood cells into their tumor would strengthen the immune system to fight against their cancer.

Key facts

Study ID

NCT00365872

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

17

Starts

2006-05-01

Expected to finish

2012-06-01

Last updated by the study team

2017-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Intermediate or high grade sarcoma as determined by pathology review
• Musculoskeletal tumor in extremities, trunk or chest wall.
• Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter.
• Clinical Stage T2N0M0 (AJCC 6th edition)
• Patient is not a candidate for neoadjuvant chemotherapy.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
• No steroid therapy within 4 weeks of first dendritic cell administration.
• No coagulation disorder.
• Patient's written informed consent.
• No contraindication to resection.
• Adequate organ function (measured within a week of beginning treatment).
• White blood count (WBC) > 3,000/mm to the third power and absolute neutrophil count (ANC) >1500/mm to the third power
• Platelets > 100,000/mm to the third power
• 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 radiation.

You may not qualify if…

• Retroperitoneal location.
• Gastrointestinal stromal tumor (GIST).
• Demonstrated metastatic disease.
• Prior radiation therapy if the current tumor is locally recurrent after prior resection.
• Concurrent treatment with any anticancer agent other than radiation as dictated by the protocol.
• Bleeding disorder.
• H.I.V. infection or other primary immunodeficiency disorder.
• Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate).
• 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).
• ECOG performance status of 2, 3 or 4.

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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