Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Antineoplastic Agents

Antibodies

Immunoglobulins

Iodine

Cadexomer iodine

Altretamine

Immunologic Factors

Patients will receive a single I-V infusion of 4mCi-10mCi/10mg 124I-huA33 in 5-30 mL of 5% human serum albumin (HAS) in normal saline, over 5 minutes-4 hours. Patients will be studied with 124I-huA33 positron-emission tomography (PET) and ex-vivo quantitation of tumor uptake .

Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV, on and before or after PET scanning on subsequent days.

Surgery (or biopsy) will be scheduled to occur 8- 10 days after administration of 124I-huA33. The 8-10 day imaging session will be scheduled for the morning of surgery or biopsy, approximately 1-6 hours before the procedure.

Patients will receive a single intravenous or intraarterial infusion of 10mg huA33, labeled with 4mCi-10mCi of 124I in 5-30ml of 5% HSA in normal saline (NS), over 5-10 minutes. On study days 2, 3, and/or 4 patients will have the option to receive up to 2g/kg of IVIG. Patients will be evaluated with 124I-huA33 positron-emission tomography (PET) with ex vivo quantitation of tumor uptake.

Iodine-124 labeled humanized A33 (antibody)

Neeta Pandit-Taskar, MD

The purpose of this study is to determine whether our drug, 124I-huA33, can safely detect colorectal cancer.

This is an open-label, pilot study of a single 4mCi-10mCi/10mg IV dose of 124I-huA33 in patients with colorectal cancer. Patients will be studied with 124I-huA33 positron-emission tomography (PET), and in the subset of patients scheduled for surgery, based on clinical indications, ex vivo quantitation of tumor uptake will also be performed. Patients will receive a single intravenous or intraarterial infusion of 4 mCi-10mCi /10mg 124I-huA33 in 5-30ml of 5% human serum albumin (HSA), over 5-10 minutes. Patient will either receive the 124I-huA33 intravenously (IV) or intraarterially (IA) to determine if there is an advantage of the IV vs the IA route. Following injection with 124I-huA33, on study days 2, 3, and/ or 4, patients will have the option to receive up to 2g/1kg of Immune Globulin (IVIG).

Blood samples will be obtained for pharmacokinetic analysis at 5, 15, 60, and 120 minutes after completion of IV or IA infusion, on day 2, 3, and/ or 4, and before and after the PET scan on the day of surgery or last imaging day (day 8 + 3). Patients scheduled for surgery will undergo a PET scan of the abdomen and pelvis 1-6 hours prior to surgery.

In those patients undergoing surgery, surgery (or biopsy) will be scheduled to occur day 8 (± 3 days) days after administration of 124I-huA33. Biopsy sites may include tumor, tumor bed, regional nodes, portal, suprapancreatic, celiac nodes and the retroperitoneum. Tumor and normal tissue obtained at surgery (or biopsy), and serum will be measured for estimation of percent-injected dose per gram of tumor, normal liver, and serum. Tissue samples will be obtained for autoradiography and immunohistochemistry as an additional assessment of tumor targeting.

Blood samples to determine immunogenicity will be taken at baseline and at 4 weeks.

Toxicity assessments will be made throughout the study period.

Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer

A Pilot Study of Radioimmunodetection of 124-Iodine-labeled Humanized A33 Antibody (124I-huA33) in Patients With Colorectal Cancer

Ludwig Institute for Cancer Research

Memorial Sloan Kettering Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

124-Iodine-cG250 (124I-cG250)

Chaitanya R Divgi, MD

Pual Russo, MD

The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.

Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.

Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).

Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.

This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.

Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.

Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

NPV is the ratio of participants who do not have clear cell RCC to all those who had negative PET scans.

Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

Sensitivity is defined as the ratio of the proportion of the patients who have clear cell RCC based on pathology and whose PET scans are positive over the number of patients with clear cell RCC. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

Specificity is defined as the number of patients with non-clear cell RCC correctly classified divided by all non-clear cell RCC patients.

Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered a true-positive. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

All patients who enrolled in the study and received 124-Iodine-cG250 (124I-cG250).

Jonathan Skipper PhD

Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.

All patients who enrolled in the study, received 124I-cG250, had evaluable PET scans, had tissue samples analyzed and were PET-positive. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Fifteen patients were PET-positive.

Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and were PET-negative. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Ten patients were PET-negative.

Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and had a pathological diagnosis of clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Sixteen patients had clear cell renal cell carcinoma.

Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and did not have clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Nine patients did not have clear cell RCC.

Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi)/10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer	NCT00199862	Colorectal Neop... Colorectal Canc... Colorectal Tumo... COlorectal Carc...	Iodine-124 labe...	18 Years -	Memorial Sloan Kettering Cancer Center
Safety Study of Radio-labeled huA33 Antibody in Colorectal Cancer	NCT00199862	Colorectal Neop... Colorectal Canc... Colorectal Tumo... COlorectal Carc...	Iodine-124 labe...	18 Years -	Memorial Sloan Kettering Cancer Center
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.	NCT00199888	Cancer of Kidne... Kidney Cancer Renal Cancer Neoplasms, Kidn... Renal Neoplasms Renal Cell Carc... Clear Cell Rena...	124-Iodine-cG25...	18 Years -	Ludwig Institute for Cancer Research

Spots Global Cancer Trial Database for iodine 124

Every month we try and update this database with for iodine 124 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 iodine 124

Every month we try and update this database with for iodine 124 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 iodine 124 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.