Neoplasms

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Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

All Drugs and Chemicals

Immunomodulating Agents

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

* 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

Dendritic Cell (DC) Injections

Radiation was delivered 5 days per week (Monday-Friday).

Radiation therapy

Tumors were surgically resected 3-6 weeks after the completion of EBRT.

Complete Resection - Surgery for tumor removal

Scott Antonia, M.D.

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.

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.

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

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

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.

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.

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.

Postoperative wound complications were defined using NCI Common Toxicity Criteria (CTC).

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.

Cancer Treatment Research Foundation

H. Lee Moffitt Cancer Center and Research Institute

Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.

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.

Radiation was delivered 5 days per week (Monday-Friday).

Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT.

EBRT + DC Injection + Resection

COHORT 1: EBRT + DC Injection + Resection

COHORT 2: EBRT + DC Injection + Resection

COHORT 3: EBRT + DC Injection + Resection

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All evaluable participants available for follow-up at time of analysis.

Scott J. Antonia, M.D., Ph.D.

Developed Tumor Specific Response

Transient Response

Robust Response

Overall Response Rate (ORR)

Occurrence of Significant (>/= Grade 2) Toxicity

Occurrence of Postoperative Wound Complications

At One Year Follow-up

At Two Year Follow-up

At Three Year Follow-up

Participants With No Evidence of Disease at Follow-up

DC injection # 4 given 24 hours prior to surgery

Single Arm - Cohort 1

DC injection # 4 given 48 hours prior to surgery

Single Arm - Cohort 2

DC injection # 4 given 72 hours prior to surgery

Single Arm - Cohort 3

Number of Participants With Increase in Level of Radioactivity at Excision Per Cohort

Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma	NCT00365872	Soft Tissue Sar...	Dendritic Cell ... Radiation thera... Complete Resect...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
External Beam Radiation With Intratumoral Injection of Dendritic Cells As Neo-Adjuvant Treatment for Sarcoma	NCT00365872	Soft Tissue Sar...	Dendritic Cell ... Radiation thera... Complete Resect...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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