Prostate Cancer Clinical Trial
— MEL-CAPOfficial 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)
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 |
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | St Bartholomews Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
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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