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A Phase II Study Evaluating Neoadjuvant Administration of High Dose Radiation Therapy and Intratumoral Autologous Dendritic Cells in Patients With High-risk Soft Tissue Sarcomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma

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Trial Information

A Phase II Study Evaluating Neoadjuvant Administration of High Dose Radiation Therapy and Intratumoral Autologous Dendritic Cells in Patients With High-risk Soft Tissue Sarcomas


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)

Outcome Description:

Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. The study will require 21 patients in each arm for a total of 42 patients.

Outcome Time Frame:

11 weeks per participant

Safety Issue:

No

Principal Investigator

Alberto Chiappori, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-16441

NCT ID:

NCT01347034

Start Date:

January 2011

Completion Date:

May 2014

Related Keywords:

  • Soft Tissue Sarcoma
  • radiation
  • neoadjuvant
  • intratumoral
  • autologous
  • dendritic cells
  • Sarcoma

Name

Location

H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Shands University of Florida Department of Radiation Oncology Gainesville, Florida  32608
Shands Jacksonville Department of Radiation Oncology Jacksonville, Florida  32206