Open-labelled, non-randomised, treatment intensifying cohort study in androgen-independent prostate cancer (AIPC.)
Conditions
Interventions
Trade Name: Alkeran
Product Name: Melphalan
Pharmaceutical Form: Injection*
INN or Proposed INN: Melphalan
CAS Number: 148-82-3
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Histological diagnosis of prostate cancer • Progressive androgen independent prostate cancer defined as: o a rising PSA; or o development of new sites of disease in the presence of a suppressed 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 o Unsupported Hb > 11.0g/l o Platelets > 100x109/l o WBC > 3x109/l o Neutrophils > 1.5x109/l Renal sufficiency o Creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: CLINICAL RESEARCH Determine safety and efficacy of intravenous melphalan + autologous whole blood stem cell transplantation in patients with androgen-independent prostate cancer TRANSLATIONAL RESEARCH 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. ; 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. ;Primary end point(s): Determine safety and efficacy of intravenous melphalan + autologous whole blood stem cell transplantation in patients with androgen-independent prostate cancer | — |
Countries
United Kingdom
Outcome results
None listed