Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001575
Status:
COMPLETED
Last Update Posted:
2015-12-07
First Post:
1999-11-03
Brief Title:
Anti-Tac90 Y-HAT to Treat Hodgkins Disease Non-Hodgkins Lymphoma and Lymphoid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-10
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:
This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac 90 Y-HAT for treating certain cancers Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body The anti-Tac antibody in this study is targeted to tumor cells and is tagged labeled with a radioactive substance called Yttrium-90 Y-90 The study will determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness
Patients 18 years of age and older with Hodgkins disease non-Hodgkins lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG chest x-ray computed tomography CT scan or ultrasound of the abdomen positron emission tomography PET scan of the neck and body and skin test for immune reactivity to antigens similar to skin tuberculin test
Before beginning treatment participants may undergo additional procedures including the following
Patients with suspicious skin lesions have a skin biopsy An area of skin is numbed and a circular piece of skin about 14-inch diameter is removed with a cookie cutter-like instrument
Patients with hearing loss have a hearing test
Patients with neurological symptoms have a lumbar puncture spinal tap A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord A small amount of fluid is collected through the needle
Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle
Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be safely given The first group of three patients receives a low dose and if there are no significant side effects at that dose the next three patients receive a higher dose This continues with subsequent groups until the maximum study dose is reached 90 Y-HAT is given through a vein intravenous IV over a 2-hour period In addition a drug called Pentetate Calcium Trisodium Inj Ca-DTPA is given via IV over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT In some patients the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what happens to the injected material During infusion of the drug patients undergo PET scanning to trace the path of the injected material in the body For this procedure the patient lies in the scanner remaining in one position during the entire infusion
Blood and urine specimens are collected periodically over a 6-week period following the infusion to determine the level of the radioactive antibody Bone marrow lymph node or skin biopsies may be done to determine how much of the antibody entered these sites Patients whose disease remains stable or improves with therapy may receive up to six more infusions of 90 Y-HAT with at least a 6-week interval between treatments
Patients 18 years of age and older with Hodgkins disease non-Hodgkins lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG chest x-ray computed tomography CT scan or ultrasound of the abdomen positron emission tomography PET scan of the neck and body and skin test for immune reactivity to antigens similar to skin tuberculin test
Before beginning treatment participants may undergo additional procedures including the following
Patients with suspicious skin lesions have a skin biopsy An area of skin is numbed and a circular piece of skin about 14-inch diameter is removed with a cookie cutter-like instrument
Patients with hearing loss have a hearing test
Patients with neurological symptoms have a lumbar puncture spinal tap A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord A small amount of fluid is collected through the needle
Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle
Patients receive 90 Y-HAT in escalating doses to determine the highest dose that can be safely given The first group of three patients receives a low dose and if there are no significant side effects at that dose the next three patients receive a higher dose This continues with subsequent groups until the maximum study dose is reached 90 Y-HAT is given through a vein intravenous IV over a 2-hour period In addition a drug called Pentetate Calcium Trisodium Inj Ca-DTPA is given via IV over 5 hours for 3 days to help reduce the side effects of the 90Y-HAT In some patients the 90 Y-HAT may also be attached to a radioactive metal called Indium-111 to monitor what happens to the injected material During infusion of the drug patients undergo PET scanning to trace the path of the injected material in the body For this procedure the patient lies in the scanner remaining in one position during the entire infusion
Blood and urine specimens are collected periodically over a 6-week period following the infusion to determine the level of the radioactive antibody Bone marrow lymph node or skin biopsies may be done to determine how much of the antibody entered these sites Patients whose disease remains stable or improves with therapy may receive up to six more infusions of 90 Y-HAT with at least a 6-week interval between treatments
Detailed Description:
Background
Cluster of differentiation 25 CD25 is expressed on the malignant cells of patients with certain lymphoid malignancies as well as the non-malignant T cells that surround the malignant tumor cells of patients with Hodgkins disease
Zenapax is a humanized monoclonal antibody that binds to CD25
Zenapax has been chemically modified by the addition of a chelating molecule to permit binding of radioactive yttrium
The yttrium labeled Zenapax binds to CD25 to deliver radiation treatment to the tumor
Objective
To assess the toxicity and therapeutic efficacy of 90Yttrium-labeled humanized anti-Tac90Y-HAT in patients with Tac-expressing hematologic malignancies
To determine the sites of localization of radiolabeled Zenapax
Eligibility
Patients with Hodgkins disease and other CD25 positive lymphoid malignancies
The patient must have a granulocyte of at least 1200mm3 and a platelet count of greater than 100000mm3
Design
Patients will be treated with 10 mCi if a bone marrow transplant was part of the patients previous therapy or 15 mCi of yttrium labeled Zenapax
Indium labeled Zenapax is given to demonstrate the antibody distribution and confirm localization at sites of tumor
Treatment is given every six weeks if tolerated and patients will be hospitalized for about one week for each treatment
Tumor response will be evaluated after every treatment Stable or responding patients will continue treatment with evaluations after every cycle of treatment Patients will be treated for up to seven cycles
Cluster of differentiation 25 CD25 is expressed on the malignant cells of patients with certain lymphoid malignancies as well as the non-malignant T cells that surround the malignant tumor cells of patients with Hodgkins disease
Zenapax is a humanized monoclonal antibody that binds to CD25
Zenapax has been chemically modified by the addition of a chelating molecule to permit binding of radioactive yttrium
The yttrium labeled Zenapax binds to CD25 to deliver radiation treatment to the tumor
Objective
To assess the toxicity and therapeutic efficacy of 90Yttrium-labeled humanized anti-Tac90Y-HAT in patients with Tac-expressing hematologic malignancies
To determine the sites of localization of radiolabeled Zenapax
Eligibility
Patients with Hodgkins disease and other CD25 positive lymphoid malignancies
The patient must have a granulocyte of at least 1200mm3 and a platelet count of greater than 100000mm3
Design
Patients will be treated with 10 mCi if a bone marrow transplant was part of the patients previous therapy or 15 mCi of yttrium labeled Zenapax
Indium labeled Zenapax is given to demonstrate the antibody distribution and confirm localization at sites of tumor
Treatment is given every six weeks if tolerated and patients will be hospitalized for about one week for each treatment
Tumor response will be evaluated after every treatment Stable or responding patients will continue treatment with evaluations after every cycle of treatment Patients will be treated for up to seven cycles
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 |
|---|---|---|---|
| 97-C-0110 | None | None | None |