Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062933
Status:
COMPLETED
Last Update Posted:
2012-08-20
First Post:
2003-06-17
Brief Title:
A Phase II Study of Isolated Hepatic Perfusion IHP in Patients With Ocular Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Isolated Hepatic Perfusion IHP With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ocular melanoma or cancer of the eye is a rare form of cancer that can spread to the liver A tumor in the liver because of its size or location sometimes cannot be removed with surgery
The purpose of this study is to determine whether chemotherapy delivered only to the liver called isolated hepatic perfusion IHP followed by systemic to the whole body chemotherapy improves the ability to treat cancer
Study participants must be 18 years or older and have ocular melanoma that has spread to the liver Before enrolling in the study they will undergo the following evaluations a physical exam x-rays blood tests electrocardiogram computed tomography CT scan of the chest abdomen and pelvis and a magnetic resonance imaging MRI scan of the liver
The study includes a 15-minute quality-of-life questionnaire Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress
A laparotomy is done which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans When this happens the participant is ineligible to continue in the study since an important part of the treatment is given only to the liver
If the laparotomy reveals that the participant is eligible for the remainder of the study the participant will receive IHP treatment during the surgery Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver This creates a separate blood supply for the liver alone Heated chemotherapy is then given into the liver blood supply for one hour while being carefully kept out of the rest of the body
After recovering from the surgery eligible participants will receive a systemic chemotherapy called temozolomide for up to one year This chemotherapy is taken by mouth in capsule form
Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress
The purpose of this study is to determine whether chemotherapy delivered only to the liver called isolated hepatic perfusion IHP followed by systemic to the whole body chemotherapy improves the ability to treat cancer
Study participants must be 18 years or older and have ocular melanoma that has spread to the liver Before enrolling in the study they will undergo the following evaluations a physical exam x-rays blood tests electrocardiogram computed tomography CT scan of the chest abdomen and pelvis and a magnetic resonance imaging MRI scan of the liver
The study includes a 15-minute quality-of-life questionnaire Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress
A laparotomy is done which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans When this happens the participant is ineligible to continue in the study since an important part of the treatment is given only to the liver
If the laparotomy reveals that the participant is eligible for the remainder of the study the participant will receive IHP treatment during the surgery Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver This creates a separate blood supply for the liver alone Heated chemotherapy is then given into the liver blood supply for one hour while being carefully kept out of the rest of the body
After recovering from the surgery eligible participants will receive a systemic chemotherapy called temozolomide for up to one year This chemotherapy is taken by mouth in capsule form
Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress
Detailed Description:
Patients with unresectable hepatic metastases secondary to ocular melanoma will undergo a 60 minute hyperthermic isolated hepatic perfusion with 15mgkg melphalan followed by up to one year of oral temozolomide Response to treatment duration of response patterns of failure survival and quality of life end-points will be followed
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 |
|---|---|---|---|
| 03-C-0221 | None | None | None |