Colorectal CancerPhase 1NCT00010270
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
A Phase 1 study testing LMB-9 immunotoxin in people with Colorectal Cancer and Esophageal Cancer, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- What is being tested?
- LMB-9 immunotoxin
- How many people
- 50 participants
- Where
- 1 siteGermany
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach that is refractory to standard treatment
- Overexpression of the Lewis-Y antigen
- Measurable or evaluable disease
- No CNS metastasis
- Metastatic liver disease from primary tumor allowed
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 3 months
Hematopoietic:
- Platelet count greater than 100,000/mm^3
- Absolute granulocyte count greater than 1,200/mm^3
Hepatic:
- Bilirubin normal
- SGOT and SGPT no greater than 1.5 times upper limit of normal
- Hepatitis B or C antigen negative
- No liver disease (e.g., alcohol liver disease)
- Albumin at least 3.0 g/dL
Renal:
- Creatinine no greater than 1.4 mg/dL
- Creatinine clearance at least 60 mL/min
- Proteinuria no greater than 1 g/24 hours (grade II toxicity-like)
Cardiovascular:
- No prior coronary artery disease
- No New York Heart Association class II, III, or IV congestive heart failure
- No arrhythmia requiring treatment
Pulmonary:
- FEV_1 and FVC greater than 65% predicted
Other:
- No other concurrent malignancy
- No active peptic ulcer disease
- No known allergy to omeprazole
- No known seizure disorder
- No concurrent medical or psychiatric condition that would preclude study participation
- No contraindication to pressor therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy:
- At least 3 weeks since prior hormonal therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma
RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer.
PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
Read the detailed description
OBJECTIVES:
- Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the clinical response of patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
- Being tested
- LMB-9 immunotoxin
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, stage III pancreatic cancer, stage II pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV gastric cancer, adenocarcinoma of the stomach, recurrent gastric cancer, adenocarcinoma of the esophagus, stage IV esophageal cancer, stage III esophageal cancer, recurrent esophageal cancer, stage II esophageal cancer, adenocarcinoma of the rectum, stage III colon cancer, stage III rectal 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.
LMB-9 immunotoxinBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Peter Hafkemeyer, MD, Study chair, Kreiskrankenhaus Emmendingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010270
- Sponsor's protocol ID
- CDR0000068462
- Other IDs
- UFMC-431, UFMC-IND-7697, UFMC-NSC-691236, NCI-431, EU-20120
- Status last verified
- Jan 2007
- First submitted
- 2 Feb 2001
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Of LMB-9, A Recombinant Disulfide Stabilized Anti-Lewis Y Immonutoxin Administered By 5-Days Continuous Infusion For Patients With Colorectal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00010270
- Acronym / sponsor ID
- CDR0000068462
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, stage III pancreatic cancer, stage II pancreatic cancer, recurrent pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2001
- First posted
- 27 Jan 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: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer.
PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
Detailed description
OBJECTIVES:
- Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen.
- Determine the maximum tolerated dose of this drug in these patients.
- Determine the clinical response of patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| LMB-9 immunotoxin | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Peter Hafkemeyer, MD study chair
Kreiskrankenhaus Emmendingen
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 LMB-9 immunotoxin in people with Colorectal Cancer and Esophageal Cancer, run by University Hospital Freiburg at 1 site in Germany.
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 19 Dec 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 Germany. 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?
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 19 Dec 2013.