Trial Outcomes & Findings for A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma (NCT NCT00843830)
NCT ID: NCT00843830
Last Updated: 2015-12-08
Results Overview
The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.
TERMINATED
PHASE1
4 participants
10 weeks
2015-12-08
Participant Flow
Participant milestones
| Measure |
Treatment Arm
tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan.
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|---|---|
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Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study Assessing Intra-Metastasis Administration of Autologous KLH-pulsed Dendritic Cells With Tumoral Radiation Therapy in Patients With Metastatic Pancreatic Carcinoma
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=4 Participants
tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan.
|
|---|---|
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Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.
The primary objective of this study was to evaluate the safety and feasibility of this combined modality protocol in patients with metastatic pancreatic carcinoma. The treatment will be deemed feasible if 80% or more patients complete radiation therapy, all three vaccinations, and evaluation for tumor response four weeks after the third vaccination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct.
To evaluate the anti-tumor response as determined by RECIST criteria
Outcome measures
Outcome data not reported
Adverse Events
Treatment Arm
Serious adverse events
| Measure |
Treatment Arm
n=4 participants at risk
tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan.
|
|---|---|
|
General disorders
Declining Performance Status
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Treatment Arm
n=4 participants at risk
tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)
Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.
Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan.
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|---|---|
|
Investigations
Alanine transaminase (ALT)
|
50.0%
2/4 • Number of events 2
|
|
Investigations
Aspartate aminotransferase (AST)
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Alkaline Phosphatase
|
50.0%
2/4 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia, Recurrent
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Difficulty Urinating
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 2
|
|
General disorders
Fatigue, Recurrent
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
High colored urine
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 3
|
|
General disorders
Pain
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
Additional Information
Mark Zalupski, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place