Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy

NCT01422850 | Completed Phase 1 Results

• 1 other identifier: CV002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumor cells and in this way stop or slow down the progression of disease.

Conditions

Hormone-refractory Prostate Cancer

Keywords

hormone-refractory prostate cancer; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes). AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not.

  At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25

• Blood Pressure, Pulse and Temperature

  Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.

  At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25

Secondary Outcomes (1)

• The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.

  Within 12 weeks

Interventions

ALECSAT BIOLOGICAL

Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.

Eligibility Criteria

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

You may qualify if:

• Serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
• Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 % increases over the PSA nadir.
• Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary hormonal manipulations, or progression of osseous or soft tissue lesions.
• Be over the age of 18 and capable of understanding the information and giving informed consent.
• Expected survival time (life expectancy) of over 6 months.
• Adequate performance status better than 2 (WHO/ECOG Performance status score).

You may not qualify if:

• A low blood count (haemoglobin \< 6.0 mmol/l).
• Lymphocyte counts below 0.8 x 109/l.
• Positive tests for anti-HIV-1/2; HBsAg, anti-HBc (Hepatitis B Core Antigen) and Anti-HCV (Hepatitis C Virus).
• Syphilis i.e. being positive in a Treponema Pallidum test.
• Uncontrolled serious bacterial, viral, fungal or parasitic infection.
• Clinically significant autoimmune disorders or conditions of immune suppression.
• 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 side effects difficult.

Sponsors & Collaborators

• CytoVac A/S: lead

Study Sites (1)

Department of Urology

Frederikssund, DK-3600, Denmark

Location

Results Point of Contact

• Title: Christer Lundell-Ek, Project Manager - Clinical Development
• Organization: CytoVac A/S

cle@cytovac.dk

Study Officials

• Hans-Henrik Meyhoff, MD

  Department of Urology, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 24, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 23, 2014
• Results First Posted: April 23, 2014

Record last verified: 2014-03

Locations

DK (1)