Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment.

blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.

Blood Samples

Christopher Barker, MD

The purpose of this study is to develop blood tests and urine tests that can tell doctors how much radiation a person has been exposed to. Doctors know how much radiation patients are exposed to in certain medical situations. An example of this would be radiation treatment for cancer. Radiation treatment machines are programmed to give exact doses of radiation.

MSKCC patients undergoing TBI as part of a hematopoietic stem cell transplant (HSCT) will have blood drawn and urine collected for use in the validation and refinement of new methods for rapid high-throughput radiation biodosimetry. These blood and urine samples will be collected before, and at defined times after TBI. Blood sampling will occur in the same manner that it does during routine patient care during HSCT.

Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)

The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.

Georgetown University

National Institute of Standards and Technology

Memorial Sloan Kettering Cancer Center

Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Cytarabine

Immunoglobulins

Immunologic Factors

This is a phase I, dose-escalation trial. The starting dose level will be 0.5 μCi/kg of 225Ac-HuM195. Three to six patients will be treated at each dose level, and dose escalation will proceed if less than 33% of patients in a cohort experience dose limiting toxicity. Six patients will be treated at the maximum tolerated dose

A single infusion of 225Ac-HuM195 will be administered at a starting dose of 0.5 μCi/kg. Additionally, 100 mCi of 213Bi-HuM195 have been administered with full dose cytarabine (200 mg/m2 daily for 5 days) without dose-limiting toxicity.Serial sampling of blood, urine, and bone marrow will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antileukemic effects. Three to six patients will be treated at each dose level. Dose escalation will proceed if less than 33% of patients in a cohort experience dose-limiting toxicity.Patients will be followed until completion of therapy as outlined in the study, loss to follow-up, death, or until the day the patient is removed from the study.

ACTINIUM-225-LABELED HUMANIZED ANTI-CD33 MONOCLONAL ANTIBODY HuM195

Dan Douer, MD

The purpose of this study is to find a safe dose of actinium-225 when it is labeled to HuM195. This will be done with a "phase I trial," in which a preset schedule of doses gets more powerful for each new group of patients as the trial progresses. If too many serious side effects are seen with a certain dose, no one will be treated with a higher dose, and some additional patients may be treated with a lower dose to make sure that this dose is safe. The starting dose of actinium-225 in this study is less than doses that are known to be safe in animals.

Antibodies are proteins that are produced by the immune system and help the body to fight foreign substances, such as bacteria or viruses. HuM195 was made by putting human leukemia cells into mice. Most of the mouse parts of this antibody were replaced with human parts. Only the part of the antibody that binds to the leukemia cells was kept from the mouse. HuM195 attaches to leukemia cells but does not attach to most normal cells. It can kill small amounts of disease by identifying the leukemia cells as "foreign." HuM195 has worked less well against large amounts of leukemia since the normal immune cells needed to kill leukemia cells are lowered in most patients with leukemia.

Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies

Phase I Trial of Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies

National Cancer Institute (NCI)

Actinium Pharmaceuticals

Immune System Diseases

Infections

Lymphoma

Sarcoma

Sarcoma, Kaposi

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Connective and Soft Tissue

Communicable Diseases

Herpesviridae Infections

Virus Diseases

DNA Virus Infections

Neoplasms, Vascular Tissue

Lymphosarcoma

Soft Tissue Sarcoma

Kaposi Sarcoma

David Straus, MD

The purpose of this study is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non-AIDS associated malignancies.

The National Cancer Institute has set up a Bank for tissues and biological fluids from HIVpositive and HIV-negative individuals in order to have specimens available for scientists studying malignancies associated with HIV disease.

The overall goal of the AIDS and Cancer Specimen Bank is to obtain clinical specimens from pathologists and physicians involved in the diagnosis and care of patients with AIDS and non- AIDS associated malignancies. These specimens will be banked and linked to a clinical data set so that experimental results obtained by analysis of specific specimens can be linked to relevant clinical data. Contents of the ACSB will be made available to researchers through an application to the National Cancer Institute. Strict patient confidentiality protection guidelines are in place for all specimens in the ACSB. The objective of this protocol is to obtain clinical specimens from potential participants in clinical trials conducted by the AIDS Malignancies Consortium, and from other patients with and without HIV infection, who have AIDS-Associated malignancies.

Blood, urine, other bodily fluids (eg, pleural fluid), and tumor tissue obtained from patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)	NCT00581958	Cancer	Blood Samples	4 Years - 100 Years	Memorial Sloan Kettering Cancer Center
Targeted Atomic Nano-Generators (Actinium-225-Labeled Humanized Anti-CD33 Monoclonal Antibody HuM195) in Patients With Advanced Myeloid Malignancies	NCT00672165	Leukemia Myelodysplastic...	ACTINIUM-225-LA...	-	Memorial Sloan Kettering Cancer Center
Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)	NCT00581958	Cancer	Blood Samples	4 Years - 100 Years	Memorial Sloan Kettering Cancer Center
AIDS and Cancer Specimen Bank (ACSB)	NCT00587912	Kaposi's Sarcom... Kaposi's Sarcom... Non-Hodgkin's L... HEMATOPOIETIC S... Cancer AIDS		18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for hematopoietic system