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2-Fluoro-2-deoxyglucose

Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.

For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.

Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.

At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.

Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.

Recurrences following resection for colorectal carcinoma occur in 50% of patients. Early detection and management of recurrences results in improved survival. Post-operative surveillance consists of serial CT scans, chest x-rays, colonoscopy and CEA determinations. Elevations in the serum CEA level can be the earliest and most sensitive indicator of recurrence. A rise in the serum CEA level in the absence of imageable disease presents a particular diagnostic challenge. Advanced imaging modalities such as Positron Emission Tomography (PET) and anti-CEA antibody immunoscintigraphy have been proposed as a way of localizing disease in these patients. This study will evaluate the sensitivity, specificity, accuracy and predictive value of FDG-PET scans and anti-CEA immunoscintigraphy in patients following resection of colorectal carcinoma who have rising serum CEA values in the absence of imageable disease by conventional modalities. Patients who meet inclusion criteria will undergo FDG-PET scan and anti-CEA immunoscintigraphy followed by an exploratory laparotomy. Abdominal explorations will be conducted by two surgeons, one of whom will be blinded to the results of the FDG-PET and CEA scans. All suspicious lesions will be biopsied and if possible resected. Results at operation will be correlated with the results of the scans. The goal of the study is to determine the role of FDG-PET scanning and anti-CEA immunoscintigraphy in the localization of recurrent colorectal carcinoma in patients with rising serum CEA levels.

Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities

National Cancer Institute (NCI)

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Leukemia, Lymphoid

Lymphoma

Lymphoma, Non-Hodgkin

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

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Hodgkin Lymphoma

Anti-Inflammatory Agents

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Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

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Pentetic Acid

Calcium, Dietary

Daclizumab

Hormones

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Iron

Iron Chelating Agents

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities	NCT00001568	Colorectal Neop...	2-Fluoro-2-deox...	-	National Institutes of Health Clinical Center (CC)
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)

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