External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: Dendritic Cell (DC) Injections; Radiation therapy; Complete Resection - Surgery for tumor removal
Intervention description: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation.
One additional DC injection was given before surgery to assess DC migration
Patients were assigned to one of three cohorts:
Group 1 - DC injection # 4 given 24 hours prior to surgery Group 2 - DC injection # 4 given 48 hours prior to surgery Group 3 - DC injection # 4 given 72 hours prior to surgery; Radiation was delivered 5 days per week (Monday-Friday).; Tumors were surgically resected 3-6 weeks after the completion of EBRT.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sarcoma; Intratumoral injection; Dendritic cells; Neo-adjuvant treatment; Immunotherapy; Pheresis; Radiation

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.