Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00129753 |
Recruitment Status :
Withdrawn
(Terminated due to slow accrual.)
First Posted : August 12, 2005
Last Update Posted : November 8, 2018
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | August 11, 2005 | |||
First Posted Date ICMJE | August 12, 2005 | |||
Last Update Posted Date | November 8, 2018 | |||
Actual Study Start Date ICMJE | June 22, 2005 | |||
Actual Primary Completion Date | September 5, 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Response Rate [ Time Frame: 1 Year ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease | |||
Official Title ICMJE | Phase II Study of Alemtuzumab (Campath-1H) Monoclonal Antibody in Patients With Relapsed and Resistant Classical Hodgkin's Disease | |||
Brief Summary | Primary Objective: To determine the safety and efficacy of Campath-1H (Alemtuzumab) in patients with relapsed and resistant classical Hodgkin's lymphoma. Secondary Objectives:
|
|||
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 Hodgkin's 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 and/or 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 Hodgkin's 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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE |
|
|||
Intervention ICMJE | Drug: Alemtuzumab (Campath-1H)
Escalating dose 3mg, 10 mg, 30 mg on three consecutive days, then 30 mg three times per week by subcutaneous injections for 12 weeks. Each 30 mg dose will be divided in 2 injections to be administered in each thigh.
Other Names:
|
|||
Study Arms ICMJE | Experimental: Alemtuzumab
Intervention: Drug: Alemtuzumab (Campath-1H)
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Enrollment ICMJE |
35 | |||
Actual Study Completion Date ICMJE | September 5, 2006 | |||
Actual Primary Completion Date | September 5, 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00129753 | |||
Other Study ID Numbers ICMJE | 2004-0742 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Anas Younes, M.D. / Professor, UT MD Anderson Cancer Center | |||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | M.D. Anderson Cancer Center | |||
Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |