Trial Outcomes & Findings for Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy (NCT NCT01422850)

Last Updated: 2014-04-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

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

Results posted on

2014-04-23

Participant Flow

The subjects was recruited consecutively. The subjects were hospitalized on the day ALECSAT was administered and also one day after the first administration. The overall study period for each participating patient was 25 weeks. The subjects were followed closely during 12 weeks after last treatment by planned study visits.

Participant milestones

Participant milestones
Measure	ALECSAT After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
Overall Study STARTED	21
Overall Study Week 4 - First Treatment	21
Overall Study Week 5	20
Overall Study Week 9 - Second Treatment	20
Overall Study Week 14 - Third Treatment	19
Overall Study Week 15	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	ALECSAT After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
Overall Study Physician Decision	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALECSAT n=21 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	16 Participants n=93 Participants
Age, Continuous Mean age	71 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Region of Enrollment Denmark	21 participants n=93 Participants

PRIMARY outcome

Timeframe: 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

Population: No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.

Outcome measures

Outcome measures
Measure	ALCESAT n=21 Participants
Adverse Events Total numbers of Adverse Events (AE)	67 Events
Adverse Events AE judged as related to study product	8 Events
Adverse Events Number of Serious Adverse Events (SAE)	9 Events
Adverse Events SAE judged as related to study product	0 Events
Adverse Events Safety issues identified by EORTC	0 Events

PRIMARY outcome

Timeframe: 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 were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.

Outcome measures

Outcome measures
Measure	ALCESAT n=21 Participants
Blood Pressure, Pulse and Temperature Significant abnormal changes in Blood pressure	0 participants
Blood Pressure, Pulse and Temperature Significant abnormal changes in Pulse	0 participants
Blood Pressure, Pulse and Temperature Significant abnormal changes in temperature	0 participants

SECONDARY outcome

Timeframe: Within 12 weeks

No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.

Outcome measures

Outcome measures
Measure	ALCESAT n=21 Participants
The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed. Trends towards possible treatment response	11 participants
The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed. No trends of possible treatment response	8 participants
The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed. Not evaluable patients	2 participants

Adverse Events

ALECSAT

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ALECSAT n=21 participants at risk
Musculoskeletal and connective tissue disorders Back pain radiating to legs	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Increased blood Creatinine	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Musculoskeletal and connective tissue disorders Leg pain	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Ureter obstruction	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders General physical health deterioration	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Vascular disorders Femoral artery bypass	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Musculoskeletal and connective tissue disorders Hip fracture	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Cardiac disorders Paroysmal atrial fibrillation	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.

Other adverse events

Other adverse events
Measure	ALECSAT n=21 participants at risk
Eye disorders Allergic conjunctivitis	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Vascular disorders Noose bleed	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Respiratory, thoracic and mediastinal disorders Bronchitis	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Dizziness	14.3% 3/21 • Number of events 3 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.5% 2/21 • Number of events 2 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Fever	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Gastrointestinal disorders Gastroenteritis	14.3% 3/21 • Number of events 3 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Warm but no fever	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Vascular disorders Hematoma	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Hydronephros	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Flu	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Skin and subcutaneous tissue disorders Lip sore/cold	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Micturition disorder	9.5% 2/21 • Number of events 2 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Pain	52.4% 11/21 • Number of events 16 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
General disorders Tiredness	14.3% 3/21 • Number of events 4 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Musculoskeletal and connective tissue disorders Traumatic injury	33.3% 7/21 • Number of events 8 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Skin and subcutaneous tissue disorders Pruritus	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Eye disorders Blurred visison	9.5% 2/21 • Number of events 2 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Respiratory, thoracic and mediastinal disorders Cold	9.5% 2/21 • Number of events 3 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Gout	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Renal and urinary disorders Increased creatinine level	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Musculoskeletal and connective tissue disorders Knee surgery	4.8% 1/21 • Number of events 1 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanom	4.8% 1/21 • Number of events 2 • 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 At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.

Additional Information

Christer Lundell-Ek, Project Manager - Clinical Development

CytoVac A/S

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60