Trial Outcomes & Findings for Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS) (NCT NCT01347034)

Last Updated: 2016-05-23

Results Overview

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. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

11 weeks per participant

Results posted on

2016-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Active Comparator: External Beam Radiation Therapy (RT) Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
Overall Study STARTED	6	14
Overall Study COMPLETED	6	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: External Beam Radiation Therapy (RT) n=6 Participants Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection n=14 Participants Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description	Total n=20 Participants Total of all reporting groups
Age, Continuous	53.8 years n=93 Participants	59.5 years n=4 Participants	57.35 years n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants	10 Participants n=4 Participants	13 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	10 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	6 participants n=93 Participants	14 participants n=4 Participants	20 participants n=27 Participants

PRIMARY outcome

Timeframe: 11 weeks per participant

Population: All participants

Outcome measures

Outcome measures
Measure	Active Comparator: External Beam Radiation Therapy (RT) n=6 Participants Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection n=14 Participants Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)	2 participants	5 participants

SECONDARY outcome

Timeframe: 11 weeks per participant

Population: All participants

Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.

Outcome measures

Outcome measures
Measure	Active Comparator: External Beam Radiation Therapy (RT) n=6 Participants Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection n=14 Participants Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) Treatment Emergent SAEs	0 participants	0 participants
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs) Treatment Emergent Other AEs	6 participants	14 participants

Adverse Events

Active Comparator: External Beam Radiation Therapy (RT)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Experimental: External Beam RT + DC Injection

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Comparator: External Beam Radiation Therapy (RT) n=6 participants at risk Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection n=14 participants at risk Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
Blood and lymphatic system disorders Anemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.

Other adverse events

Additional Information

Alberto Chiappori, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-3050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Comparator: External Beam Radiation Therapy (RT) n=6 participants at risk Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description	Experimental: External Beam RT + DC Injection n=14 participants at risk Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
General disorders Fatigue	33.3% 2/6 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.	57.1% 8/14 • Number of events 11 • 2 years, 2 months All adverse events, regardless of causality.
General disorders Pain	50.0% 3/6 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.	35.7% 5/14 • Number of events 11 • 2 years, 2 months All adverse events, regardless of causality.
General disorders Edema limbs	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	28.6% 4/14 • Number of events 7 • 2 years, 2 months All adverse events, regardless of causality.
General disorders Chills	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.
General disorders Injection site reaction	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
General disorders Irritability	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	78.6% 11/14 • Number of events 12 • 2 years, 2 months All adverse events, regardless of causality.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	50.0% 7/14 • Number of events 7 • 2 years, 2 months All adverse events, regardless of causality.
Skin and subcutaneous tissue disorders Erythema multiforme	50.0% 3/6 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.	0.00% 0/14 • 2 years, 2 months All adverse events, regardless of causality.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	28.6% 4/14 • Number of events 7 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	28.6% 4/14 • Number of events 7 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	21.4% 3/14 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	21.4% 3/14 • Number of events 4 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 4 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Investigations Lymphocyte count decreased	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	42.9% 6/14 • Number of events 11 • 2 years, 2 months All adverse events, regardless of causality.
Investigations Alkaline phosphatase increased	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	21.4% 3/14 • Number of events 4 • 2 years, 2 months All adverse events, regardless of causality.
Investigations Weight loss	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Investigations Alanine aminotransferase increased	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Investigations White blood cell decreased	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.	28.6% 4/14 • Number of events 4 • 2 years, 2 months All adverse events, regardless of causality.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	16.7% 1/6 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.	0.00% 0/14 • 2 years, 2 months All adverse events, regardless of causality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	50.0% 7/14 • Number of events 10 • 2 years, 2 months All adverse events, regardless of causality.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Nausea	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	28.6% 4/14 • Number of events 4 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Constipation	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Gastrointestinal disorders Dry mouth	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Nervous system disorders Dizziness	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Nervous system disorders Headache	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Infections and infestations Infections and infestations - Other	50.0% 3/6 • Number of events 3 • 2 years, 2 months All adverse events, regardless of causality.	0.00% 0/14 • 2 years, 2 months All adverse events, regardless of causality.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.	0.00% 0/14 • 2 years, 2 months All adverse events, regardless of causality.
Vascular disorders Hypertension	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	14.3% 2/14 • Number of events 2 • 2 years, 2 months All adverse events, regardless of causality.
Vascular disorders Hematoma	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Cardiac disorders Palpitations	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Endocrine disorders Endocrine disorders - Other	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • 2 years, 2 months All adverse events, regardless of causality.	7.1% 1/14 • Number of events 1 • 2 years, 2 months All adverse events, regardless of causality.