A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP). (MEL-CAP)
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|ClinicalTrials.gov Identifier: NCT01907009|
Recruitment Status : Unknown
Verified July 2013 by Barts & The London NHS Trust.
Recruitment status was: Recruiting
First Posted : July 24, 2013
Last Update Posted : September 9, 2015
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 place. Following the failure of such an approach, several strategies may be employed. Both corticosteroids and estrogens have a role and increasingly chemotherapy is being used. The demonstration of enhanced survival using 3 weekly docetaxel has meant that this is viewed by many as the standard of care for fit patients.
Melphalan is an established alkylating drug that has demonstrated some activity in CRPC, but to date, myelosuppression has prevented adequate dosing. We have recently conducted a phase I dose escalation study using melphalan and whole blood stem cell re-infusion and it shows that median overall survival is 22 months, which is higher than the median survival rate of 19 months for Docetaxel
Data from a previous phase I study has proved the successful administration of higher doses of IV Melphalan in combination with autologous blood infusion in patients with Castration-resistant prostate cancer.
Rapid falls in circulating tumour cells were seen within 2 weeks of starting Melphalan, however slow platelet recovery meant longer periods of platelet transfusion. For this study we intend to assess the efficacy of an intensified intravenous melphalan with autologous whole blood stem cell transplantation over three treatment cycles.
39 patients will be enrolled over a 3 year period and at least 17 patients need to survive progression free at least 6-months for this study to be considered positive.
Mel-CAP is a combination chemotherapy consisting of two chemotherapy drugs:
MELPHALAN and LENOGRASTIM for 3 cycles alternately.
|Condition or disease||Intervention/treatment||Phase|
|Castrate Resistant Prostate Cancer||Drug: Melphalan Drug: Lenograstim||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PHASEII STUDY EVALUATING INTRAVENOUS MELPHALAN WITH AUTOLOGOUS WHOLE BLOOD STEM CELL TRANSPLANTATION (PBSCT)OVER THREE CYCLES IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (MEL-CAP).|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||September 2017|
MELCAP study has only one arm. All suitable patients will receive 3 cycles of melphalan and lenograstim alternately.
Patient will start with a 3 day lenograstim (at 10mcg/kg/day) to boost up the blood cell count.
Upon reaching sufficient blood cell count, patients will undergo a venesection and roughly a pint of blood is taken. After this patients will receive first cycle of Melphalan (60mg/m2). The following day patient will receive back the previously given whole blood. A treament break of 6 days between the cycles is given. After the break the patient will be given Lenograstim (10mcg/kg/day)for 6 days (until sufficient).
The above regimen is repeated for cycle 2 and cycle 3 with only exception of Melphalan is given at 40mg/m2. After the cycle 3, Lenograstrim is given at 263 mcg/day for 10 days.
Upon treatment completion, patients will be followed for 2 years. If the patients show disease progression, they will start hormone therapy.
Patients will receive Melphalan in three cycles In the first cycle they recieve 60mg/m2 and then 40mg/m2 in the next two cycles.
Starting Lenograstim will be at 10mcg/kg/day and between cycles at 10mcg/kgs/day.
After the third cycle patient will receive 263mcg/day for 10 days.
- To determine the efficacy of intensified intravenous Melphalan with autologous whole blood stem cell transplantation in patients with castration resistant prostate cancer using progression free survival. [ Time Frame: 6 months progression free survival ]
- To determine weather early falls (two weeks)in circulating tumor cells (CTC)predict the progression free survival [ Time Frame: 2 weeks ]
- To assess the changes in prostate specific antigen pre and post treament [ Time Frame: 6 months ]
- To study progression free survival and overall survival [ Time Frame: 6 months. ]
- To assess the effect of this schedule in reintroduction of hormone senstivity [ Time Frame: 6 months ]
- To study the Quality of life. [ Time Frame: 6 months ]QLQ-30 and PR-25 questionnaires will be collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907009
|Contact: Jonathan Shamash, MD FRCPfirstname.lastname@example.org|
|St Batholowmew's Hospital NHS||Recruiting|
|London, United Kingdom, EC1A 7BE|
|Principal Investigator:||Jonathan Shamash, MD FRCP||Barts & The London NHS Trust|