A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.
18 Years
N/A
Male
Hormone-refractory Prostate Cancer
Trial Information
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.
This study is a prospective open phase I study to investigate the safety and tolerability of
administration of repeated doses of a cell based medicinal product (CBMP) ALECSAT.
ALECSAT is an autologous CBMP that is made from the patient's own blood cells. ALECSAT
contains a large amount of tumour specific cytotoxic Lymphocytes (CTL) and Natural Killer
(NK) cells that are isolated activated and amplified in number.
The CBMP is given as a slow i. v. injection to patients with prostate cancer. The patients
are in the late stage of the disease where they have received hormone treatment but their
disease is progressing.
The primary objective of the study is to observe if any side effects or tolerability issues
occur as a consequence of the repeated administration of ALECSAT, secondarily it will be
observed if changes in PSA levels or any positive anti tumor effect may be observed. The
study has the purpose to investigate whether repeated treatment with ALECSAT in any way is
toxic.
Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate
cancer patients.
A group consisting of 4 patients will be treated twice with ALECSAT according to the
protocol. Then an interim analysis will be done. If there are no signs of significant
toxicity related to the treatment, the study will continue to the third treatment for these
patients and with 14 more patients that will be treated with ALECSAT according to the
protocol. Thus this study will include a total of 20 patients.
The patients will after the first administration of ALECSAT be hospitalized for 2 days. Five
and 10 weeks later the patients will be hospitalized for 1 day and receive the second and
third administration of ALECSAT. Each patient will furthermore be followed closely for 12
weeks after the third treatment. During the course of the entire study the patients will be
monitored by 11 planned study visits, by the investigators at Urologisk Klinik at
Fredrikssund Hospital.
Inclusion Criteria:
1. Serum castration levels of testosterone, (total testosterone under 1.7nmol/l).
2. Three consecutive rises of PSA minimum 1 week apart, resulting in at least two 50 %
increases over the PSA nadir.
3. Antiandrogen withdrawal for at least 4 weeks, or PSA progression despite secondary
hormonal manipulations, or progression of osseous or soft tissue lesions.
4. Be over the age of 18 and capable of understanding the information and giving
informed consent.
5. Expected survival time (life expectancy) of over 6 months.
6. Adequate performance status better than 2 (WHO/ECOG Performance status score).
Exclusion Criteria:
1. A low blood count (haemoglobin < 6.0 mmol/l).
2. Lymphocyte counts below 0.8 x 109/l.
3. Positive tests for anti-HIV-1/2; HBsAg, anti-HBc and Anti-HCV.
4. Syphilis i.e. being positive in a Treponema Pallidum test.
5. Uncontrolled serious bacterial, viral, fungal or parasitic infection.
6. Clinically significant autoimmune disorders or conditions of immune suppression.
7. Treatment with corticosteroids (steroid hormones) or bisphosphonates or have been in
chemotherapy or radiation treatment one month prior to inclusion in the clinical
trial.
8. Blood transfusions within 48 hours prior to donation of blood for ALECSAT production.
9. Inclusion in other clinical trials 6 weeks prior to inclusion in the trial or
enrolment in other clinical trials during the ALECSAT clinical trial.
10. Any medical condition that will render participation in the study risky or, according
to the Investigator will make the assessment of side effects difficult.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary endpoint is to show safety and tolerability for the repeated administration of ALECSAT to enable further clinical development of the ALECSAT therapy.
Outcome Description:
To show safety and tolerability patients will be monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status will be monitored. Blood samples will be analysed for: PSA, ALP, LDH, CREAT and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes). The number of patients experiencing adverse events (AE), the number and duration of the AE will be reported as a measure of safety and tolerability.
Outcome Time Frame:
Within 12 weeks
Safety Issue:
Yes
Principal Investigator
Hans-Henrik Meyhoff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Urologisk Klinik, Frederikssund Hospital, Frederikssundsvej 30, 3600 Frederikssund
Authority:
Denmark: Danish Medicines Agency
Study ID:
CV002
NCT ID:
NCT01422850
Start Date:
August 2011
Completion Date:
October 2012
Related Keywords:
- Hormone-Refractory Prostate Cancer
- hormone-refractory prostate cancer
- Immunotherapy
- Prostatic Neoplasms
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