Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129753
Status:
WITHDRAWN
Last Update Posted:
2018-11-08
First Post:
2005-08-11
Brief Title:
Alemtuzumab Campath-1H Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkins Disease
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Alemtuzumab Campath-1H Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkins Disease
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To determine the safety and efficacy of Campath-1H Alemtuzumab in patients with relapsed and resistant classical Hodgkins lymphoma
Secondary Objectives
1 To determine the duration of response and time to progression after Campath-1H therapy in this patient population
2 To determine the effect of Campath-1H on serum IL-6 IL-10 and IL-13 levels in patients with relapsed and resistant classical Hodgkins lymphoma
To determine the safety and efficacy of Campath-1H Alemtuzumab in patients with relapsed and resistant classical Hodgkins lymphoma
Secondary Objectives
1 To determine the duration of response and time to progression after Campath-1H therapy in this patient population
2 To determine the effect of Campath-1H on serum IL-6 IL-10 and IL-13 levels in patients with relapsed and resistant classical Hodgkins lymphoma
Detailed Description:
Alemtuzumab is the type of drug known as a monoclonal antibody The antibody binds to a specific protein antigen called CD52 CD52 is found on the surface of normal lymphocytes and monocytes When the antibody binds to the protein on the surface of the lymphocyte or monocyte it causes the cell to die The goal of the study is to learn if killing normal lymphocytes and monocytes with alemtuzumab will result in regression lessening of the cancer cells
Alemtuzumab is usually given by an infusion into a vein However in this study it will be given as an injection under-the-skin This method of giving alemtuzumab is not approved by the FDA The purpose of giving the drug by injection under the skin is to decrease the side effects observed with infusion by vein
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam Blood about 2 tablespoons will be collected for routine tests A bone marrow sample will be collected to learn if your Hodgkins lymphoma has spread to the bone marrow To collect a bone marrow sample biopsy an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle A CT scan or MRI of the chest abdomen stomach and pelvis waist area will be done You will also have a PET scan or a Gallium scan to check on the status of the disease You will be required to have a heart scan or an echocardiogram to check how strong your heart muscle is You will be asked about medications that you are currently taking including over-the-counter medications Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will receive alemtuzumab 3 times a week as an injection under the skin Typically these injections will be given on Monday Wednesday and Friday Each dose will be divided into two injections to be given in each thigh You will be treated for 12 weeks in a row The treatment doses will be given by a nurse at M D Anderson in an outpatient setting Before each injection you may receive Tylenol andor Benadryl to decrease the risk of side effects caused by the study drug
During the 12-week treatment course in addition to your study drug injections you will visit the clinic every 3 weeks for physical exam and routine blood tests 2 tablespoons each You will also have a blood test 1 tablespoonful every week to find out if you are having a certain type of viral infection cytomegalovirus called CMV If your blood tests show that your CMV blood levels are increasing you may need treatment with anti-viral antibiotics to control your viral infection You doctor will also give you antibiotics to take by mouth to prevent possible infections
If the tumor grows during treatment or you experience any intolerable very bad side effects you will be taken off study and your doctor will discuss other treatment options with you
Within 3 weeks of the last dose of alemtuzumab you will have a physical exam routine blood tests 2 tablespoons CT scans of the chest abdomen and pelvis and a bone marrow biopsy if needed These tests will help show whether your tumor is shrinking after therapy If these tests show that your tumor is not growing you will be placed on observation and your tumor status will be checked up on every 3 months by repeating similar tests
This is an investigational study Alemtuzumab is FDA approved for the treatment of chronic lymphocytic leukemia and is commercially available However the FDA has not approved alemtuzumab for the treatment of Hodgkins disease Furthermore the FDA has not approved the injection of alemtuzumab under the skin for the treatment of cancer A maximum of 35 patients will take part in this study All will be enrolled at M D Anderson
Alemtuzumab is usually given by an infusion into a vein However in this study it will be given as an injection under-the-skin This method of giving alemtuzumab is not approved by the FDA The purpose of giving the drug by injection under the skin is to decrease the side effects observed with infusion by vein
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete medical history and physical exam Blood about 2 tablespoons will be collected for routine tests A bone marrow sample will be collected to learn if your Hodgkins lymphoma has spread to the bone marrow To collect a bone marrow sample biopsy an area of the hip bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle A CT scan or MRI of the chest abdomen stomach and pelvis waist area will be done You will also have a PET scan or a Gallium scan to check on the status of the disease You will be required to have a heart scan or an echocardiogram to check how strong your heart muscle is You will be asked about medications that you are currently taking including over-the-counter medications Women who are able to have children must have a negative blood pregnancy test
If you are found to be eligible to take part in this study you will receive alemtuzumab 3 times a week as an injection under the skin Typically these injections will be given on Monday Wednesday and Friday Each dose will be divided into two injections to be given in each thigh You will be treated for 12 weeks in a row The treatment doses will be given by a nurse at M D Anderson in an outpatient setting Before each injection you may receive Tylenol andor Benadryl to decrease the risk of side effects caused by the study drug
During the 12-week treatment course in addition to your study drug injections you will visit the clinic every 3 weeks for physical exam and routine blood tests 2 tablespoons each You will also have a blood test 1 tablespoonful every week to find out if you are having a certain type of viral infection cytomegalovirus called CMV If your blood tests show that your CMV blood levels are increasing you may need treatment with anti-viral antibiotics to control your viral infection You doctor will also give you antibiotics to take by mouth to prevent possible infections
If the tumor grows during treatment or you experience any intolerable very bad side effects you will be taken off study and your doctor will discuss other treatment options with you
Within 3 weeks of the last dose of alemtuzumab you will have a physical exam routine blood tests 2 tablespoons CT scans of the chest abdomen and pelvis and a bone marrow biopsy if needed These tests will help show whether your tumor is shrinking after therapy If these tests show that your tumor is not growing you will be placed on observation and your tumor status will be checked up on every 3 months by repeating similar tests
This is an investigational study Alemtuzumab is FDA approved for the treatment of chronic lymphocytic leukemia and is commercially available However the FDA has not approved alemtuzumab for the treatment of Hodgkins disease Furthermore the FDA has not approved the injection of alemtuzumab under the skin for the treatment of cancer A maximum of 35 patients will take part in this study All will be enrolled at M D Anderson
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