Colorectal CancerPhase 1/2NCT00102024
Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma
A Phase 1/2 study testing Unconjugated IDEC-159, 111In-IDEC-159 and 90Y-IDEC-159 in people with Colorectal Cancer and Metastases, run by Biogen at 1 site in United States.
Trial summary
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Metastases
- What is being tested?
- Unconjugated IDEC-159, 111In-IDEC-159 and 90Y-IDEC-159
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jan 2006
- Phase
- Phase 1/2
- 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
Who may be able to join
- Sign an Institutional Review Board (IRB)-approved informed consent.
- Metastatic colorectal adenocarcinoma that has been pathologically confirmed following failed response or relapse while on or following fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy. (Prior therapy with cetuximab is recommended if the tumors are epidermal growth factor receptor [EGFR] positive.)
- Age 18 or above.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Recovered to baseline toxicity from any significant toxicity associated with prior surgery, chemotherapy, biological therapy, or investigational drug.
- Adequate bone marrow reserve (absolute neutrophil count > 1500 cells/mm3, platelet count > 125,000 cells/mm3, hemoglobin concentration ≥ 10 g/dL).
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- Radiographically measurable disease (RECIST criteria).
- Life expectancy of at least 3 months.
- Male and female subjects of reproductive potential must agree to follow accepted birth control methods, as determined by the investigator, during treatment and for 12 months after completion of treatment.
Who cannot join
- Prior radioimmunotherapy.
- Known presence of central nervous system (CNS) metastasis.
- Any lesion > 7.5 cm.
- Total bilirubin > 2.0 mg/dL.
- Total creatinine > 2.0 mg/dL.
- AST and ALT > 2.5 times upper limit of normal (ULN), if metastases to the liver > 5 times ULN.
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- Presence of a second primary malignancy requiring active treatment (except for hormonal therapy).
- Serious non-malignant disease or infection that, in the opinion of either the investigator or sponsor, would compromise protocol objectives.
- History of external beam radiation therapy to > 25% of active bone marrow.
- History of bone marrow or stem cell transplant.
- History of granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony stimulating factor (GM-CSF) therapy within 2 weeks before Study Day 1.
- History of pegylated G-CSF therapy within 4 weeks before Study Day 1.
- History of major surgery, other than diagnostic surgery, within 4 weeks of Study Day 1.
- History of receiving investigational product within 4 weeks before Study Day 1 or long term toxicity from a previous investigational therapy.
- Known history of HIV or AIDS.
- Concurrent systemic corticosteroid therapy or other immunosuppressive agents, unless for the treatment of computed tomography (CT) dye allergy reactions.
- Pregnant or lactating female.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
About this study
Official title: A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.
- Conditions
- Colorectal Cancer, Metastases
- Being tested
- Unconjugated IDEC-159, 111In-IDEC-159, 90Y-IDEC-159
- Keywords
- Metastatic Colorectal Adenocarcinoma, Anti TAG-72, Monoclonal Antibody
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconjugated IDEC-159Drug
111In-IDEC-159Drug
90Y-IDEC-159Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.
Secondary outcomes (1)
To evaluate activity; blood, normal organ, and tumor dosimetry; the immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 (sTAG-72) levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2005 (estimated)
- Study startJan 2005
- Primary completionJan 2006
- Study completionJan 2006
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 BiogenThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andres Forero, M.D., Principal investigator, Comprehensive Cancer Center, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102024
- Sponsor's protocol ID
- 159-01
- Status last verified
- Aug 2010
- First submitted
- 19 Jan 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159, Humanized, Domain Deleted, Anti TAG-72 Monoclonal Antibody, in Subjects With Metastatic Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00102024
- Acronym / sponsor ID
- 159-01
- Conditions
- Colorectal Cancer, Metastases
- Keywords
- Metastatic Colorectal Adenocarcinoma, Anti TAG-72, Monoclonal Antibody
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 30 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 20 Jan 2005 (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.
This is a Phase I/II open-label, dose-escalating study in patients with metastatic colorectal cancer. The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159, as well as its activity in colorectal cancer. Another objective is to determine the maximum tolerated dose (MTD). The study duration is 2 years with visits occuring daily and/or weekly for the first 3 months, and every 6 weeks until the end of the 2 year period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign an Institutional Review Board (IRB)-approved informed consent.
- Metastatic colorectal adenocarcinoma that has been pathologically confirmed following failed response or relapse while on or following fluoropyrimidine, irinotecan, and oxaliplatin chemotherapy. (Prior therapy with cetuximab is recommended if the tumors are epidermal growth factor receptor [EGFR] positive.)
- Age 18 or above.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Recovered to baseline toxicity from any significant toxicity associated with prior surgery, chemotherapy, biological therapy, or investigational drug.
Key exclusion criteria (17 listed)
- Prior radioimmunotherapy.
- Known presence of central nervous system (CNS) metastasis.
- Any lesion > 7.5 cm.
- Total bilirubin > 2.0 mg/dL.
- Total creatinine > 2.0 mg/dL.
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 |
|---|---|---|
| Unconjugated IDEC-159 | Drug | – |
| 111In-IDEC-159 | Drug | – |
| 90Y-IDEC-159 | Drug | – |
Primary outcome
To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.
1 secondary outcome
To evaluate activity; blood, normal organ, and tumor dosimetry; the immunogenicity and pharmacokinetics of 90Y-IDEC-159; and its effect on soluble TAG-72 (sTAG-72) levels.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
Andres Forero, M.D. principal investigator
Comprehensive Cancer Center, University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Unconjugated IDEC-159, 111In-IDEC-159 and 90Y-IDEC-159 in people with Colorectal Cancer and Metastases, run by Biogen 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?
The sponsor lists 9 inclusion and 17 exclusion criteria. 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: stopped early, as of the sponsor's last update on 27 Aug 2010. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
To characterize the safety profile and determine the MTD of 90Y-IDEC-159 in subjects with metastatic colorectal cancer.. 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 27 Aug 2010.