Colorectal CancerPhase 1NCT00895323
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
A Phase 1 study testing enzyme-linked immunosorbent assay, pharmacological study and whole-body scintigraphy in people with Colorectal Cancer, run by Garden State Cancer Center at the Center for Molecular Medicine and Immunology at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- enzyme-linked immunosorbent assay, pharmacological study and whole-body scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Radiological documentation of disease is preferred, but not required
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm³
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine normal
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT < 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 1 month after completion of study therapy
- No medical conditions that might prevent full participation in protocol-required testing or follow-up
- No institutionalized patients (e.g., in prisons or mental health institutions)
PRIOR CONCURRENT THERAPY:
- No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Clinical Trials Office - Lombardi Comprehensive Cancer Center, 202-444-0381
About this study
Official title: Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.
PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
Read the detailed description
OBJECTIVES:
- Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.
OUTLINE: This is a multicenter study.
Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.
Blood samples are collected at baseline and periodically after ^131I-TF2 infusion for pharmacokinetic studies and ^131I-TF2 biodistribution by ELISA and radioactivity measurements.
- Conditions
- Colorectal Cancer
- Being tested
- enzyme-linked immunosorbent assay, pharmacological study, whole-body scintigraphy, iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enzyme-linked immunosorbent assayOther
whole-body scintigraphyProcedure or surgery
iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Tissue distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startNov 2008
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Garden State Cancer Center at the Center for Molecular Medicine and Immunology
- Sponsor type
- University, hospital or other
- Investigators
- Aiwu R. He, MD, Principal investigator, Lombardi Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895323
- Sponsor's protocol ID
- CDR0000636332
- Other IDs
- CMMI-C-071A-07
- Status last verified
- Jul 2009
- First submitted
- 7 May 2009
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
- ClinicalTrials.gov ID
- NCT00895323
- Acronym / sponsor ID
- CDR0000636332
- Conditions
- Colorectal Cancer
- Keywords
- stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Garden State Cancer Center at the Center for Molecular Medicine and ImmunologyUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (estimated)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.
PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
Detailed description
OBJECTIVES:
- Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.
OUTLINE: This is a multicenter study.
Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.
Blood samples are collected at baseline and periodically after ^131I-TF2 infusion for pharmacokinetic studies and ^131I-TF2 biodistribution by ELISA and radioactivity measurements.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enzyme-linked immunosorbent assay | Other | – |
| pharmacological study | Other | – |
| whole-body scintigraphy | Procedure or surgery | – |
| iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2 | Radiation | – |
Primary outcome
Pharmacokinetics
Tissue distribution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., United States
Aiwu R. He, MD principal investigator
Lombardi Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing enzyme-linked immunosorbent assay, pharmacological study and whole-body scintigraphy in people with Colorectal Cancer, run by Garden State Cancer Center at the Center for Molecular Medicine and Immunology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013; AzTrials last refreshed its copy on 8 Nov 2026.