Colorectal CancerPhase 1NCT00025532
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
A Phase 1 study testing iodine I 131 monoclonal antibody CC49-deltaCH2 in people with Colorectal Cancer and Esophageal Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for gastrointestinal cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- What is being tested?
- iodine I 131 monoclonal antibody CC49-deltaCH2
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to not given
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the esophagus, stomach, pancreas, colon, or rectum More than 30% positively immunoreactive to monoclonal antibody CC49 in the metastatic or primary lesion OR TAG-72 antigen serum level greater than 15 Measurable or evaluable unresectable or metastatic disease by CT scan
PATIENT CHARACTERISTICS: Age: 19 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 150,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL ALT and AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) PTT less than 37.0 seconds INR less than 2.0 Renal: Creatinine less than 2.0 mg/dL Other: No known allergy to murine immunoglobulin No iodine allergy No concurrent illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be ambulatory and able to comply with study schedule
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine immunoglobulin Chemotherapy: Prior or concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
About this study
Official title: A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for gastrointestinal cancer.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer.
Read the detailed description
OBJECTIVES: I. Determine the biodistribution and biokinetics of iodine I 131-labeled monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma. II. Determine the human anti-human monoclonal antibody response in patients treated with this drug.
OUTLINE: Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 (131I MOAB CC49-delta CH2) IV over 5-10 minutes on day 0. Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28. Patients are followed weekly for 4 months and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
- Being tested
- iodine I 131 monoclonal antibody CC49-deltaCH2
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus, adenocarcinoma of the colon, adenocarcinoma of the rectum, adenocarcinoma of the pancreas, stage IV pancreatic cancer
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iodine I 131 monoclonal antibody CC49-deltaCH2Other
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2003 (estimated)
- Study startApr 2001
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.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Margaret A. Tempero, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025532
- Sponsor's protocol ID
- CDR0000068971
- Other IDs
- UCSF-H11156-18101-02, UCSF-00455, NCI-T97-0054
- Status last verified
- Sep 2012
- First submitted
- 11 Oct 2001
- Last updated
- 14 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas
- ClinicalTrials.gov ID
- NCT00025532
- Acronym / sponsor ID
- CDR0000068971
- Keywords
- stage III colon cancer, stage IV colon cancer, stage III gastric cancer, stage IV gastric cancer, recurrent gastric cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage III rectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- First posted
- 21 Nov 2003 (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: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for gastrointestinal cancer.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer.
Detailed description
OBJECTIVES: I. Determine the biodistribution and biokinetics of iodine I 131-labeled monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma. II. Determine the human anti-human monoclonal antibody response in patients treated with this drug.
OUTLINE: Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 (131I MOAB CC49-delta CH2) IV over 5-10 minutes on day 0. Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28. Patients are followed weekly for 4 months and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 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 |
|---|---|---|
| iodine I 131 monoclonal antibody CC49-deltaCH2 | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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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.
Margaret A. Tempero, MD study chair
University of California, San Francisco
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 iodine I 131 monoclonal antibody CC49-deltaCH2 in people with Colorectal Cancer and Esophageal Cancer, run by University of California, San Francisco 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: withdrawn, as of the sponsor's last update on 14 Sep 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 14 Sep 2012.