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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02349347
Other study ID # MEL-CAP
Secondary ID
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. completion date
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


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
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