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Study closed early secondary to inability to obtain grant funding to conduct.
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This study is being done to determine whether it is possible to use an investigational vaccine that consists of dendritic cells in patients with pancreas cancer. Dendritic cells are immune cells that are obtained from your blood that are important in the body's immune response to foreign substances. The vaccine would be injected directly into a tumor that has spread to the liver after a short course of radiation therapy has been given to that tumor. The study will try to determine if this treatment would be safe and effective in treating this cancer.
This is a phase 1 pilot study of this treatment. Phase 1 trials test the best way to give a treatment where little is known about its possible risks or benefits. Phase 2 studies then test the possible benefits of a treatment and may show the specific situations where they are seen. Promising treatments are then tested in Phase 3 trials which compare the new treatment to standard treatment in a larger group of patients. Phase 4 trials are those conducted on a treatment after it has been approved for general use outside of research. A pilot study tests a treatment in a small number of patients to learn if and how the treatment could be tested in a larger group. Pilot studies can be performed at any phase but are commonly performed in the earliest phases of research on a treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants will receive tumoral irradiation and dendritic cell vaccination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tumoral irradiation | Radiation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination. | 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients That Respond to Treatment | To evaluate the anti-tumor response as determined by RECIST criteria | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark M. Zalupski, M.D. | Universtiy of Michigan Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dendritic cell vaccination | Biological | Three intra-tumoral injections of 1 ml cell suspensions of KLH (keyhole limpet hemocyanin)- pulsed DC (dendritic cells) will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting. |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants That Patients Complete Radiation Therapy, All Three Vaccinations, and Evaluation for Tumor Response Four Weeks After the Third Vaccination. | 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. | The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct. | Posted | 10 weeks |
|
| |||||||||||||||||||
| Secondary | Number of Patients That Respond to Treatment | To evaluate the anti-tumor response as determined by RECIST criteria | The primary objective could not be evaluated. The study was closed early secondary to inability to obtain grant funding to conduct. | Posted | 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Declining Performance Status | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine transaminase (ALT) | Investigations |
| |||
| Aspartate aminotransferase (AST) | Investigations |
| |||
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
| |||
| Alkaline Phosphatase | Investigations |
| |||
| Anemia, Recurrent | Blood and lymphatic system disorders |
| |||
| Anorexia | Metabolism and nutrition disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Difficulty Urinating | Renal and urinary disorders |
| |||
| Fatigue | General disorders |
| |||
| Fatigue, Recurrent | General disorders |
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| High colored urine | Renal and urinary disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Pain | General disorders |
| |||
| Vomiting | Gastrointestinal disorders |
|
The study was closed early secondary to inability to obtain grant funding to conduct.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Zalupski, M.D. | University of Michigan Comprehensive Cancer Center | 734-615-3969 | zalupski@umich.edu |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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