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

February 20, 2017 updated by: H. Lee Moffitt Cancer Center and Research Institute

Combination of External Beam Radiation With Intratumoral Injection of Dendritic Cells as Neo-adjuvant Treatment of High-risk Soft Tissue Sarcoma Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBRT + DC Injection + Resection
Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts as outlined in that intervention.
Biological: Dendritic Cell (DC) Injections
  • 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

Procedure: Radiation therapy
Radiation was delivered 5 days per week (Monday-Friday).
Procedure: Complete Resection - Surgery for tumor removal
Tumors were surgically resected 3-6 weeks after the completion of EBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 3 years
Immune responses in patients treated with EBRT and DCs: Transient immune response = response detected at only one time point; Robust immune response = response detected at least at two time points. An individual patient was considered a responder to tumor cell lysates (TCL) or survivin if at any time point the response in the interferon gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) assay was higher than 30 spots per 2 X 10^5 cells and in the proliferation assay higher than 3,000 counts per minute (CPM) and the response in IFN-γ ELISPOT or proliferation assays to TCL or Ad-surv was more than 2 standard deviations (SD) higher than the response to the corresponding control lysate or Ad-c at the same time point and 2 SD higher than the response to the same stimuli before start of the treatment.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Significant (>/= Grade 2) Toxicity
Time Frame: Up to 3 years
Toxicity assessment during combination external beam radiation therapy (EBRT)/DC neoadjuvant treatment. Toxicity was assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria.
Up to 3 years
Occurrence of Postoperative Wound Complications
Time Frame: Up to 3 years
Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).
Up to 3 years
Participants With No Evidence of Disease at Follow-up
Time Frame: 3 years
Participants who had no evidence of the disease for at least one year after the start of the treatment (time of follow-up); for at least 2 years, and for at least 3 years.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort
Time Frame: Up to 3 years
To identify the nodes to be excised, an injection with Indium 111 (radio active dye) labeled dendritic cells (of vaccine #4) was performed 1 to 3 days prior to surgery. Patients were evenly divided to be assigned to one of three cohorts: Cohort 1, 1 day before surgery; Cohort 2, 2 days before surgery; Cohort 3, 3 days before surgery. Vaccine #4 was labeled in order to evaluate how long dendritic cells need to travel to regional draining lymphatics. Tumor resection was not delayed by this.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Cancer Treatment Research Foundation

Investigators

  • Principal Investigator: Scott Antonia, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-14497

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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