A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients

NCT01984658 | Completed Phase 1

• 2 other identifiers: CV-0042013-001907-35
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 24 weeks

Secondary Outcomes (1)

• Efficacy; Tumor change

  Up to 24 weeks

Other Outcomes (2)

• Efficacy; Lab parameters

  Up to 24 weeks

• Safety & efficacy; Quality of life

  Up to 24 weeks

Study Arms (1)

Alecsat

EXPERIMENTAL

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.

Biological: Alecsat

Interventions

Alecsat BIOLOGICAL

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.

Alecsat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*),

You may not qualify if:

• 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,

Sponsors & Collaborators

• CytoVac A/S: lead

Study Sites (1)

Kirurgisk afdeling K, Bispebjerg Hospital

Copenhagen, DK-2400, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Lars T. Sørensen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 26, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)