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A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study


Phase 1
18 Years
N/A
Not Enrolling
Male
Hormone-refractory Prostate Cancer

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Trial Information

A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study


This study is a prospective open phase I study to investigate the safety and tolerability of
administration of a single dose 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 cell administration, secondarily it will be observed if any
positive anti tumour effect may be observed. The study has the purpose to investigate
whether 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 6 patients will be treated 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 with 8 more patients that will be included and
treated with ALECSAT according to the phase I protocol. Thus this study will include a total
of 14 patients.

The patients will after a single administration of ALECSAT be hospitalised for 3 days and
will furthermore be followed closely for 7 weeks by 5 planned study visits, by the
investigators at Urologisk Klinik at Fredrikssund Hospital.


Inclusion Criteria:



- Hormone-refractory prostate cancer patients

- Three consecutive rises of PSA min. 2 weeks 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.

- Serum castration levels of testosterone.

- Be capable of understanding the information and giving informed consent.

- Expected survival time (life expectancy) of over 4 months.

- Adequate performance status (WHO / ECOG Performance status score 2 or less).

Exclusion Criteria:

- Patients with a low blood count (haemoglobin < 6.0 mmol/l).

- Patients with lymphocyte-numbers below 0.8.

- Patients known to be HIV and/or hepatitis positive i.e. patients positive in tests
for anti-HIV-1/2; HBsAg, anti-HBc and Anti-HCV.

- Patients known to have syphilis i.e. being positive in a Treponema Pallidum test.

- Patients with uncontrolled serious bacterial, viral, fungal or parasitic infection.

- Patients must have no clinically significant autoimmune disorders or conditions of
immune suppression.

- Patients that have been treated with corticosteroids (steroid hormones) or
bisphosphonates or have been in chemotherapy or radiation treatment one month prior
to inclusion in the clinical trial.

- Fertile patients.

- Patients that have received blood transfusions within 48 hours prior to donation of
blood for ALECSAT production.

- Patients must not have been included in other clinical trials 6 weeks prior to
inclusion in the trial or be enrolled in other clinical trials during the ALECSAT
clinical trial.

- Any medical condition that will render participation in the study risky or, according
to the investigator in charge, 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 administration of ALECSAT to enable further clinical development of the ALECSAT therapy.

Outcome Time Frame:

Within 7 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:

CV001

NCT ID:

NCT00891345

Start Date:

April 2009

Completion Date:

July 2010

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • hormone-refractory prostate cancer
  • Immunotherapy
  • Prostatic Neoplasms

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