Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01907009
Status:
TERMINATED
Last Update Posted:
2023-04-19
First Post:
2013-07-22
Brief Title:
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
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEL-CAP
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-000351-14 | EUDRACT_NUMBER | None | None |