Status:
COMPLETED
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Cancer Treatment Research Foundation
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ti...
Detailed 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 fra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00365872
Start Date
May 1 2006
End Date
June 1 2012
Last Update
March 23 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612