A Phase 2 interventional study of External Beam Radiation Therapy (RT) and Autologous Dendritic Cells in Soft Tissue Sarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
Procedure: External Beam Radiation Therapy (RT)
Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
Procedure: External Beam Radiation Therapy (RT) · Biological: Autologous Dendritic Cells
Day 1: Start external beam RT, 25 fractions from days 1-33 administered Monday through Friday only (no conventional external beam RT on days 6, 7, 13, 14, 20, 21, 27, or 28 Days 57-70: Surgery will occur 3-5 weeks after the final dose of external beam RT. Day 78-91: First post-operative visit Days 91-365: Clinical follow-up Beyond day 365, follow-up will be conducted using the standard of care approach applicable to these patients for the determination of disease recurrence, progression and survival.
Prior to each injection on Arm B, patients may receive prophylactic doses of a first generation cephalosporin antibiotic per physician discretion. Following each DC injection, Arm B patients will assess procedure-associated pain on a scale of 0-10. The next Monday following each DC injection, the patient will be called and questioned about such procedure associated toxicities.
Also known as: immunotherapy
Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)
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).
Time frame: 11 weeks per participant
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)
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.
Time frame: 11 weeks per participant
| Milestone | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection |
|---|---|---|
| Started | 6 | 14 |
| Completed | 6 | 14 |
| Not completed | 0 | 0 |
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).
| participants | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection |
|---|---|---|
| Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs) | 2 | 5 |
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.
| participants | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection |
|---|---|---|
| Treatment Emergent SAEs | 0 | 0 |
| Treatment Emergent Other AEs | 6 | 14 |
Collected over 2 years, 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Comparator: External Beam Radiation Therapy (RT) | — | 0/6 (0%) | 6/6 (100%) |
| Experimental: External Beam RT + DC Injection | — | 1/14 (7.1%) | 14/14 (100%) |
| Event | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/6 | 1/14 |
| DehydrationMetabolism and nutrition disorders | 0/6 | 1/14 |
| Event | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection |
|---|---|---|
| Dermatitis radiationInjury, poisoning and procedural complications | 0/6 | 11/14 |
| FatigueGeneral disorders | 2/6 | 8/14 |
| PainGeneral disorders | 3/6 | 5/14 |
| Skin hyperpigmentationSkin and subcutaneous tissue disorders | 0/6 | 7/14 |
| Erythema multiformeSkin and subcutaneous tissue disorders | 3/6 | 0/14 |
| AnemiaBlood and lymphatic system disorders | 0/6 | 7/14 |
| Infections and infestations - OtherInfections and infestations | 3/6 | 0/14 |
| Lymphocyte count decreasedInvestigations | 0/6 | 6/14 |
| Edema limbsGeneral disorders | 0/6 | 4/14 |
| HyperglycemiaMetabolism and nutrition disorders | 0/6 | 4/14 |
All participants
| Age, Continuous(years) | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection | Total |
|---|---|---|---|
| Mean | 53.8 (45 to 74) | 59.5 (42 to 77) | 57.35 (42 to 77) |
| Age, Categorical(Participants) | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 10 | 13 |
| >=65 years | 3 | 4 | 7 |
| Sex: Female, Male(Participants) | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 3 | 10 | 13 |
| Region of Enrollment(participants) | Active Comparator: External Beam Radiation Therapy (RT) | Experimental: External Beam RT + DC Injection | Total |
|---|---|---|---|
| United States | 6 | 14 | 20 |
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H. Lee Moffitt Cancer Center and Research Institute