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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Completed; Phase 2

Conditions: Soft Tissue Sarcoma

Treatments: Biological: Dendritic Cell (DC) Injections; Procedure: Radiation therapy; Procedure: Complete Resection - Surgery for tumor removal

Study type: Interventional

Funder types: Other

Identifiers

NCT00365872

MCC-14497

Details and patient eligibility

About

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.

Full description

Patients were treated with external beam radiation therapy (EBRT) combined with experimental intratumoral injection of dendritic cell (DC). Patients received 5,040 centigray (cGy) EBRT in 28 equal fractions. Radiation was delivered 5 days per week (Monday-Friday). 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 several days before surgery to assess DC migration. Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

EBRT + DC Injection + Resection

Experimental group

Description:

Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention.

Treatment:

Biological: Dendritic Cell (DC) Injections

Procedure: Radiation therapy

Procedure: Complete Resection - Surgery for tumor removal