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10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Y-90 Humanized Anti-Tac

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Calcium-DTPA

Thomas A Waldmann, M.D.

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 Hodgkin's disease, non-Hodgkin's 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 1/4-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.

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 Hodgkin's 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 (90)Yttrium-labeled humanized anti-Tac((90)Y-HAT) in patients with Tac-expressing hematologic malignancies.

To determine the sites of localization of radiolabeled Zenapax.

Eligibility:

Patients with Hodgkin's disease and other CD25 positive lymphoid malignancies.

The patient must have a granulocyte of at least 1,200/mm\^3 and a platelet count of greater than 100,000/mm\^3.

Design:

Patients will be treated with 10 mCi (if a bone marrow transplant was part of the patient's 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.

Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia

Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.

Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

National Cancer Institute (NCI)

Principal Investigator

Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Thomas Waldmann M.D.

Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).

Maximum Tolerated Dose (MTD) of 90Y-HAT

Complete Response

Partial Response

Stable Disease

Progressive Disease

Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).

Clinical Response

Number of Participants With Adverse Events

Overall Study

Digestive System Diseases

Behaviors and Mental Disorders

Carcinoma

Sarcoma

Carcinoma, Hepatocellular

Liver Neoplasms

Rhabdoid Tumor

Hepatoblastoma

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplasms, Connective and Soft Tissue

Quality of Life

Soft Tissue Sarcoma

Embryonal Sarcoma

Hematinics

Liver Extracts

Evaluation of change of HRQOL survey responses will be performed:

* at baseline (time of treatment) and
* 1 month post treatment
* 6 months post treatment
* 12 months post treatment
* 5 years post-treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Quality of Life Assessment

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

* Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
* Resection Rate following treatment
* Transplant Rate following treatment
* Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
* Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
* Review of clinical course post-treatment-rehospitalization rate

Transarterial Radioembolization

Howard Katzenstein

Allison Aguado

Stephen Dunn

This study will be performed to evaluate the Clinical Outcomes and Quality of Life after Transarterial Radioembolization with Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults with Liver Tumors. The treatment and techniques used here are well established in adults.

The purpose of this study is to evaluate:

1. the response to treatment and clinical outcomes of treatment with TARE Y-90 as part of standard therapy and
2. to assess the change in the patient's quality of life before, during and after treatment with TARE-Y90

* Referral to Nemours Liver Tumor Program is made by the primary team (oncologist/surgeon).
* Phone discussion between the Nemours Liver Tumor Program Team will occur with the referring team about the patient.
* Phone call between the Nemours Liver Tumor Program Team and the family will occur prior to any visit to discuss the potential plan of care and the basics of the TARE-Y90 procedure and the Quality of Life surveys.

Review of medical records provided by referring institution will be done by the Nemours Liver Tumor Program Team including:

History, Scans-actual imaging required, Path report-slide submission required, Roadmaps, Labs, Other pertinent medical history and records

-Visit to Nemours/AI DuPont Children's Hospital for initial consultation will be arranged by the Nemours Liver Tumor Program Team.

The patient and family will meet with the team including:

Liver transplant surgeon (Dr Dunn), Interventional Radiologist (Dr Aguado), Social worker, Child life specialist, Pediatric oncologist (Dr Gresh - on site, Dr Katzenstein by telemedicine)

* Attempt will be made to schedule the pre-planning angiogram as part of initial visit (2nd day of visit). The angiogram requires the following 3-4 hours (mapping of blood vessels in and around tumor - determines whether patient can receive Y90, Angiogram is done with the patient sedated and having been after midnight the night before, The patient is expected to be discharged on the same day of the angiogram- no admit is planned but occasionally the patient may need overnight observation to occur due to age of the patient or the length of the procedure.
* Return to home.
* Potential additional single cycle of chemotherapy may be given prior to return to Nemours for Y90.

All further Chemotherapy Care is coordinated with Nemours Liver Tumor oncologists

-A 2nd visit to AIDHC will occur for TARE-Y90 treatment: The procedure lasts about 2-3 hours. There is no planned admit but possible if any problems occur.

* 2 weeks post procedure a phone call follow-up after treatment will occur with the Nemours team
* 2 weeks post procedure the patient may resume chemotherapy when cleared by the Nemours team
* 4-6 weeks post Y90 treatment - a repeat CT/MRI will be done as well as lab tests.
* If possible, the CT/MRI to be done at AIDHC/Nemours but can be done locally if travel barriers exist.
* If the tumor is now resectable, planning will be made for resection at AIDHC/Nemours.
* Evaluation and change of HRQOL survey responses will be performed at baseline (time of treatment) and 1, 6, 12 months and 5 years post-treatment. These surveys will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

Clinical Outcomes and Quality of Life After Transarterial Radioembolization With Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors

Evaluation of change of HRQOL survey responses will be performed:

-at baseline (time of treatment)

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 1 month post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 6 months post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 12 months post treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Evaluation of change of HRQOL survey responses will be performed:

- 5 years post-treatment

The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

-

Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Resection Rate following treatment

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Transplant Rate following treatment

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors

Deliver catheter directed yttrium-90 directly to liver tumors and assess

-Review of clinical course post-treatment-rehospitalization rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia	NCT00001575	Hodgkin's Disea... Lymphoma, Non-H...	Y-90 Humanized ... Calcium-DTPA	18 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Yttrium-90 (TARE-Y90) in Children, Adolescents, and Young Adults With Liver Tumors	NCT04315883	Hepatoblastoma Hepatocellular ... Rhabdoid Tumor ... Undifferentiate... Pediatric Liver... Liver Tumors	Quality of Life... Transarterial R...	0 Years - 21 Years	Nemours Children's Clinic

Spots Global Cancer Trial Database for yttrium 90

Every month we try and update this database with for yttrium 90 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for yttrium 90

Every month we try and update this database with for yttrium 90 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for yttrium 90 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.