MELCAP

• Research type

  Research Study

• Full title

  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

• IRAS ID

  103751

• Contact name

  Jonathan Shamash

• Sponsor organisation

  Barts Health NHS Trust

• Eudract number

  2012-000351-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The management of castration-resistant prostate cancer (CRPC) is becoming increasingly complex being docetaxel viewed by many as the standard of care for fit patients. Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study [EudraCT: 2006-002210-36]using melphalan with the combination of lenograstim and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 16.4 months for Docetaxel. The results of this study showed rapid improvement in pain and a fall in circulating tumour cells within two weeks of starting Melphalan. However, slow platelet recovery after the fourth cycle meant longer periods of platelet transfusion. Rapid falls in circulating tumour cells correlated with prolonged survival and on review of the data it was felt that in view of the slow recovery in platelet count it would be appropriate to reduce the number of cycles from 4 to 3. The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in combination with a transplant of the patient's own blood stem cells over a shorter time period (for a maximum of three cycles). This is a multi-centre study which will involve approximately 39 patients over a 3 year period. Patients who complete treatment will be followed up for two years post-treatment.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1138

• Date of REC Opinion

  9 Aug 2012

• REC opinion

  Favourable Opinion