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)
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Keep this study
Lead
Barts & The London NHS Trust
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Men aged ≥18 years
2. Histological diagnosis of prostate cancer
3. 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)
4. ECOG performance status 0-2
5. Adequate haematological reserve:
* Unsupported Hb \>9.0 g/l
* Platelets \>100x109/l
* WBC \>3x109/l
* Neutrophils \>1.5x109/l
6. Renal sufficiency:
•Creatinine \<200 µmol/l
7. Hepatic sufficiency:
* Bilirubin \<30 µmol/l
* ALT \<3xULN unless due to liver metastasis
8. Able to give written informed consent and comply with the protocol study procedures
You may not be if
1. Patients who have suffered a previous hypersensitivity reaction to melphalan
2. Patients with known hypersensitivity to lenograstim or to any of the excipients
3. History of myeloid malignancy
4. Lenograstim should not be administered concurrently with cytotoxic chemotherapy (i.e. on the same day)
5. Previous invasive carcinoma \<3 years prior to study entry
6. Cardiac condition contra-indicating large volume venesection (i.e., active angina or cardiac failure)
7. 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.
8. Life expectancy \<12 weeks
9. Unwilling or unable to provide written informed consent
Clareo Health | 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)
