Back to resultsA Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Alecsat
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from locally advanced pancreatic cancer and have started treatment with Folfirinox but must stop because of side effects or who declined the Folfirinox treatment.
- Minimum age of 18 years old and be capable of understanding the information and giving informed consent,
- Minimum height of 155 cm,
- Expected survival time (life expectancy) of over 6 months,
- Adequate performance status £ 2 (see below*),
Exclusion Criteria:
- Evident signs of distant metastasis at baseline
- Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
- Patient´s which have visit an area where there is an outbreak of West Nile virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative,
- Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,
- Clinically significant autoimmune disorders or conditions of immune suppression,
- Haemoglobin count ≤ 7.5 mmol/l (men & women),
- Lymphocytes below 0.3 x 109/l,
- Clinically abnormal Erythrocyte Volume Fraction (EVF),
- Body weight below 40 kg (men) and 50 kg (women),
- Pregnant or breast feeding women. Fertile women can only be included with a negative pregnancy test at screening and must use contraceptives during the study,
- Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
- Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
- Any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of the study endpoints difficult,
Sites / Locations
- Kirurgisk afdeling K, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alecsat
Arm Description
The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells. It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator. Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered. The interval between injections for continued treatment will be decided based on e.g. tumour response and clinical examinations.
Outcomes
Primary Outcome Measures
Safety and tolerability
Investigation of the safety and tolerability of administrating repeated doses of ALECSAT will be measured by recording the presence of adverse events/serious adverse events during the study period, and by following clinically significant changes in blood parameters, performance status and quality of life questionnaire at specific time points and compare with the individual patients status at baseline
Secondary Outcome Measures
Efficacy; Tumor change
Assessment of any change in tumour involvement are followed by CT (according to the RECIST 11 protocol) at specific time points and will be compared with the individual patients status at baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01984658
Brief Title
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients
Official Title
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Pancreas Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CytoVac A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.
Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.
Detailed Description
This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.
Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.
The selected group of patients suffers from locally advanced pancreatic cancer and have been treated with first line treatment regimens (e.g. surgery, radiotherapy, and/or Folfirinox) and are followed at Kirurgisk afdeling K, Bispebjerg Hospital. The subjects will be recruited consecutively and included to the study if they fulfil the inclusion criteria and do not meet any of the exclusion criteria. Potential candidates will receive oral information by the Investigator subsequent to the written patient information. The potential candidate must have the opportunity to consider the given information and to further ask the Investigator questions before finally deciding to participate. When the patient decides to take part in the study he/she will be required to sign the declaration of consent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alecsat
Arm Type
Experimental
Arm Description
The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells. It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator. Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered. The interval between injections for continued treatment will be decided based on e.g. tumour response and clinical examinations.
Intervention Type
Biological
Intervention Name(s)
Alecsat
Intervention Description
The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells. It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator. Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered. The interval between injections for continued treatment will be decided based on e.g. tumour response and clinical examinations.
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Investigation of the safety and tolerability of administrating repeated doses of ALECSAT will be measured by recording the presence of adverse events/serious adverse events during the study period, and by following clinically significant changes in blood parameters, performance status and quality of life questionnaire at specific time points and compare with the individual patients status at baseline
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Efficacy; Tumor change
Description
Assessment of any change in tumour involvement are followed by CT (according to the RECIST 11 protocol) at specific time points and will be compared with the individual patients status at baseline
Time Frame
Up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Efficacy; Lab parameters
Description
Changes in pancreatic cancer marker CA19-9, change in Haemoglobin, Lymphocytes and their subpopulations, Leucocytes, ASAT, ALAT, Amylase, Bilirubin, Glucose, LDH, Sodium and Potassium that may show trends of clinical effect at specific time points and will be compared with the individual patients status at baseline,
Time Frame
Up to 24 weeks
Title
Safety & efficacy; Quality of life
Description
Changes in the patients quality of life and performance status are measured at specific time points and will be compared with the individual patients status at baseline,
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suffering from locally advanced pancreatic cancer and have started treatment with Folfirinox but must stop because of side effects or who declined the Folfirinox treatment.
Minimum age of 18 years old and be capable of understanding the information and giving informed consent,
Minimum height of 155 cm,
Expected survival time (life expectancy) of over 6 months,
Adequate performance status £ 2 (see below*),
Exclusion Criteria:
Evident signs of distant metastasis at baseline
Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
Patient´s which have visit an area where there is an outbreak of West Nile virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative,
Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,
Clinically significant autoimmune disorders or conditions of immune suppression,
Haemoglobin count ≤ 7.5 mmol/l (men & women),
Lymphocytes below 0.3 x 109/l,
Clinically abnormal Erythrocyte Volume Fraction (EVF),
Body weight below 40 kg (men) and 50 kg (women),
Pregnant or breast feeding women. Fertile women can only be included with a negative pregnancy test at screening and must use contraceptives during the study,
Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
Any medical condition that will render participation in the study risky or, according to the investigator will make the assessment of the study endpoints difficult,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars T. Sørensen, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirurgisk afdeling K, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
DK-2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
phase 1 safety study
Learn more about this trial
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients
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