A Single Arm Phase II Study to assess the efficacy of intensified intravenous Melphalan in combination with a transplant of the patient's own blood stem cells for a maximum of three cycles in patients with castration-resistant prostate cancer (CRPC)

A PHASE II STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT) OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER - MELCAP

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000351-14-GB

Enrollment

Registered

2012-09-14

Start date

2012-10-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

castration resistant prostate cancer patients

Interventions

Trade Name: Melphalan 50 mg Injection Product Name: Melphalan 50 mg Injection Product Code: n/a Pharmaceutical Form: Concentrate for solution for inject

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Men aged =18 years 2. Histological diagnosis of prostate cancer 3. Progressive Castration-resistant Prostate Cancer defined as: • a rising PSA; or • 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) 4. ECOG performance status 0-2 5. Adequate haematological reserve • Unsupported Hb >10.0 g/l • Platelets >100x109/l • WBC >3x109/l • Neutrophils >1.5x109/l 6. Renal sufficiency: • Creatinine =65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Patients who have suffered a previous hypersensitivity reaction to melphalan 2. Patients with known hypersensitivity to lenograstim or to any of the excipients 3. History of myeloid malignancy 4. Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day) 5. Previous invasive carcinoma <3 years prior to study entry 6. Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure) 7. Current treatment with another investigational medicinal product or participation in another investigational therapeutic study, at any time during the treatment period and 30 days preceding study entry 8. Life expectancy <12 weeks 9. Unwilling or unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with Castration-resistant prostate cancer using Progression Free Survival rate; Secondary Objective: - To determine whether early falls (at two weeks) in Circulating Tumour Cells (CTC) predict for PFS - To assess the changes of PSA (pre and post treatment) - To study PFS and OS - To assess the effect of this schedule on re-induction of hormone sensitivity - To study the quality of life changes ;Primary end point(s): To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with CRPC using Progression Free Survival rate	—

Measure

Time frame

Main Objective: To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with Castration-resistant prostate cancer using Progression Free Survival rate; Secondary Objective: - To determine whether early falls (at two weeks) in Circulating Tumour Cells (CTC) predict for PFS - To assess the changes of PSA (pre and post treatment) - To study PFS and OS - To assess the effect of this schedule on re-induction of hormone sensitivity - To study the quality of life changes ;Primary end point(s): To determine the efficacy of intensified intravenous melphalan with autologous whole blood stem cell transplantation in patients with CRPC using Progression Free Survival rate

—

Countries

United Kingdom

Contacts

Public ContactJonathan Shamash

St Bartholomew's Hospital

orchidtrials@qmcr.qmul.ac.uk0207 882 8761

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026