A Phase II study evaluating intravenous Melphalan with autologous whole blood stem cell transplantation (PBSCT) in patients with Androgen –Independent Prostate Cancer (AIPC) - Melphalan in AIPC / Mel-CaP
- Conditions
- Open-labelled, non-randomised, treatment intensifying cohort study in androgen-independent prostate cancer (AIPC.)
- Registration Number
- EUCTR2006-002210-36-GB
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
•Histological diagnosis of prostate cancer
•Progressive androgen independent prostate cancer defined as:
o a rising PSA; or
odevelopment of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or
oif testosterone > 1.5nmol/l, maximum androgen blockade failure (MAB)
(MAB = GnRH analogue and peripheral anti-androgen – flutamide 250mg 3x/day or bicalutamide 50mg/ day or cyproterone 100mg 3x/day)
•ECOG performance status 0-2
•Adequate haematological reserve
oUnsupported Hb > 11.0g/l
oPlatelets > 100x109/l
oWBC > 3x109/l
oNeutrophils > 1.5x109/l
Renal sufficiency
oCreatinine <200 µmol/l
oBilirubin < 30µmol/l
oALT < 3xULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Previous invasive carcinoma < 3 years prior to study entry
•Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
•Current participation in any other investigational drug study
•Life expectancy < 12 weeks
•Unwilling or unable to provide written informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: CLINICAL RESEARCH<br> Determine safety and efficacy of intravenous melphalan + autologous whole blood stem cell transplantation in patients with androgen-independent prostate cancer<br><br> TRANSLATIONAL RESEARCH<br> To determine mechanisms of any putative endocrine sensitivity re-induction-in particular any changes in androgen receptor function in this patient population by collecting circulating prostate cancer cells from peripheral blood during whole-blood stem cell collection.<br> ;<br> Secondary Objective: Determine the level of stem cells, circulating EPCs and serum growth factors at different time points and establish whether this can be utilised as a prognostic marker.<br> ;Primary end point(s): Determine safety and efficacy of intravenous melphalan + autologous whole blood stem cell transplantation in patients with androgen-independent prostate cancer
- Secondary Outcome Measures
Name Time Method