A Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles in Patients With Castration-resistant Prostate Cancer (CRPC)

Prostate Cancer Clinical Trial

— MEL-CAP  

Official title:

A Single Arm Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles in Patients With Castration-resistant Prostate Cancer (CRPC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349347
• Other study ID #: MEL-CAP
• Status: Recruiting
• Phase: Phase 2
• First received: January 23, 2015
• Last updated: January 27, 2015
• Start date: December 2012

Study information

• Verified date: January 2015
• Source: Queen Mary University of London
• Contact: MelCAP Trial Coordinator
• Email: bci-melcap[@]qmul.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of intensified intravenous Melphalan in combination with a transplant of patients' own blood stem cells for a maximum of three cycles.

In a recently completed small Phase I study looking at the use of higher doses of intravenous Melphalan with the combination of lenograstim (a drug that stimulates bone marrow to produce white blood cells helping to fight infection) and patients' own blood infusion over 4 cycles of treatment has proved encouraging. 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. For this trial we intend to assess the efficacy of an intensified intravenous Melphalan with transplant of patients' own blood stem cells over a shorter time period. This study will involve approximately 39 patients over a 3 year period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men aged =18 years

• Histological diagnosis of prostate cancer

• Progressive Castration-resistant Prostate Cancer defined as: a rising PSA; or development of new sites of disease in the presence of a suppressed testosterone (<1.5 nmol/l); or if testosterone >1.5 nmol/l, maximum androgen blockade failure (MAB) (MAB = GnRH analogue and peripheral anti-androgen - flutamide 250 mg 3x/day or bicalutamide 50 mg/ day or cyproterone 100mg 3x/day)

• ECOG performance status 0-2

• Adequate haematological reserve: Unsupported Hb >9.0 g/l, Platelets >100x109/l, WBC >3x109/l, Neutrophils >1.5x109/l

• Renal sufficiency: Creatinine <200 µmol/l

• Hepatic sufficiency: Bilirubin <30 µmol/l, ALT <3xULN unless due to liver metastasis

• Able to give written informed consent and comply with the protocol study procedures

Exclusion Criteria:

• Patients who have suffered a previous hypersensitivity reaction to melphalan

• Patients with known hypersensitivity to lenograstim or to any of the excipients

• History of myeloid malignancy

• Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)

• Previous invasive carcinoma <3 years prior to study entry

• Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)

• Current treatment with another investigational medicinal (chemotherapeutic) product or participation in another investigational therapeutic (chemotherapy)study, at any time during the treatment period and 30 days preceding study entry.

• Life expectancy <12 weeks

• Unwilling or unable to provide written informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Melphalan

• Lenograstim

Locations

Country	Name	City	State
United Kingdom	St Bartholomews Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) rate at 6 months according to PCWG2 criteria		6 months post-registration	No