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Radio-labeled Antibody for Colorectal Cancer
N/A
Waitlist Available
Led By Neeta Pandit-Taskar, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The following laboratory results within the last 2 weeks prior to study day 1: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelet count ≥ 75 x 10^9/L, Serum bilirubin ≤ 2.5 mg/dL, Serum creatinine ≤ 2.0 mg/dL, White Blood Count (WBC) ≥ 3,000/mm^3, Age ≥ 18 years. Children of all ages are not included as colon cancer is extremely rare in children
Primary or metastatic colorectal carcinoma, histologically confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until end of study
Awards & highlights
Study Summary
This trial will test if a new drug can help safely detect colorectal cancer.
Who is the study for?
This trial is for adults with confirmed colorectal cancer who are fit enough for surgery/biopsy and have adequate organ function. They must not be pregnant, breastfeeding, or have heart disease, active brain tumors, or prior A33 treatment.Check my eligibility
What is being tested?
The study tests if a drug called 124I-huA33 can safely identify colorectal cancer in patients. It involves using a radioactive antibody to detect the presence of cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the introduction of antibodies and issues from radioactivity exposure such as nausea or changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colorectal cancer was confirmed at MSKCC.
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I am eligible for surgery or biopsy for my colorectal cancer.
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I am mostly able to care for myself and carry out daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until end of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Autoradiographs - tumor or biopsy samples
Ex vivo radioactivity estimates - tumor, normal tissue and serum samples
PET imaging/Dosimetry
+2 moreSecondary outcome measures
HAHA levels - measured by plasmon resonance surface (Biacore®) assay
Serum radioactivity, volume of distribution, and half-life following IV and IA 124I-huA33
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radio-labeled huA33 AntibodyExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,590 Total Patients Enrolled
Ludwig Institute for Cancer ResearchOTHER
60 Previous Clinical Trials
1,590 Total Patients Enrolled
Neeta Pandit-Taskar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My colorectal cancer was confirmed at MSKCC.I do not have severe heart disease.I have been treated with A33 or tested positive for huA33 HAHA.I am eligible for surgery or biopsy for my colorectal cancer.I am a woman who can have children and have a negative pregnancy test.I am not pregnant or breast-feeding.My cancer has spread to my brain.I am mostly able to care for myself and carry out daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Radio-labeled huA33 Antibody
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What findings have been made from other experiments that incorporated the use of Iodine-124 labeled humanized A33 (antibody)?
"Currently, 16 medical trials are investigating Iodine-124 labeled humanized A33 (antibody), two of which have advanced to Phase 3. 38 clinical sites around North Adelaide, South Australia offer this treatment and its associated studies."
Answered by AI
How many participants can join this clinical trial?
"This trial is not presently open for enrollment. First posted on February 1st 2004, it was last amended in April 26th 2022. If seeking other potential studies, there are 1065 trials currently accepting patients with a tumor or colorectal issue; and 16 of these involve Iodine-124 labeled humanized A33 (antibody)."
Answered by AI
What purpose does Iodine-124 labeled humanized A33 (antibody) serve?
"Iodine-124 labeled humanized A33 (antibody) is a helpful tool in combating communicable diseases, establishing antiseptic practices, and treating minor infections caused by external wounds."
Answered by AI
Is participation in this experiment still open to potential candidates?
"At this moment, recruitment for the trial has ended. The posting was initially made on February 1st 2004 and most recently revised on April 26th 2022. If you are looking to participate in other trials, 1065 studies related to tumors or colorectal remain open with 16 of them studying Iodine-124 labeled humanized A33 (antibody)."
Answered by AI
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