Status:
TERMINATED
A Phase II Study Evaluating Intravenous Melphalan With Autologous Whole Blood Stem Cell Transplantation Over Three Cycles In Patients With Castration-Resistant Prostate Cancer (MEL-CAP)
Lead Sponsor:
Barts & The London NHS Trust
Conditions:
Castrate Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The management of (castration-resistant) prostate cancer (CRPC) is becoming increasingly complex. The use of peripheral anti-androgens with gonadorelin analogues (maximum androgen blockade) is common ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01907009
Start Date
January 1 2013
End Date
December 22 2016
Last Update
April 19 2023
Active Locations (1)
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1
St Batholowmew's Hospital NHS
London, United Kingdom, EC1A 7BE