Recruitment

Recruitment Status
Completed
Estimated Enrollment
18

Inclusion Criterias

Adequate performance status £ 2 (see below*),
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.
Expected survival time (life expectancy) of over 6 months,
...
Adequate performance status £ 2 (see below*),
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.
Expected survival time (life expectancy) of over 6 months,
Minimum height of 155 cm,
Minimum age of 18 years old and be capable of understanding the information and giving informed consent,

Exclusion Criterias

Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
Clinically abnormal Erythrocyte Volume Fraction (EVF),
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,
...
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
Clinically abnormal Erythrocyte Volume Fraction (EVF),
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,
Clinically significant autoimmune disorders or conditions of immune suppression,
Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
Body weight below 40 kg (men) and 50 kg (women),
Haemoglobin count ≤ 7.5 mmol/l (men & women),
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,
Evident signs of distant metastasis at baseline
Lymphocytes below 0.3 x 109/l,
Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
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,
Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,

Summary

Conditions
Pancreatic Cancer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Masking Description: open labelPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 si...

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.

Inclusion Criterias

Adequate performance status £ 2 (see below*),
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.
Expected survival time (life expectancy) of over 6 months,
...
Adequate performance status £ 2 (see below*),
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.
Expected survival time (life expectancy) of over 6 months,
Minimum height of 155 cm,
Minimum age of 18 years old and be capable of understanding the information and giving informed consent,

Exclusion Criterias

Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
Clinically abnormal Erythrocyte Volume Fraction (EVF),
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,
...
Blood transfusions within 48 hours prior to donation of blood for ALECSAT production,
Clinically abnormal Erythrocyte Volume Fraction (EVF),
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,
Clinically significant autoimmune disorders or conditions of immune suppression,
Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis),
Body weight below 40 kg (men) and 50 kg (women),
Haemoglobin count ≤ 7.5 mmol/l (men & women),
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,
Evident signs of distant metastasis at baseline
Lymphocytes below 0.3 x 109/l,
Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection,
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,
Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation,

Locations

Copenhagen, DK-2400
Copenhagen, DK-2400

Tracking Information

NCT #
NCT01984658
Collaborators
Not Provided
Investigators
  • Principal Investigator: Lars T. Sørensen, MD Bispebjerg Hospital
  • Lars T. Sørensen, MD Bispebjerg Hospital