Status:
COMPLETED
Phase I Trial of huA33 Plus Chemotherapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Ludwig Institute for Cancer Research
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Although treatment for metastatic colorectal cancer has improved significantly over the recent years, it still remains a significant health problem representing the leading cancer by incidence in the ...
Detailed Description
Purpose of the Research Study: huA33 is an antibody that reacts with the A33 antigen which is produced by colorectal cancers. Prior studies have shown that application of the huA33 antibody may delay...
Eligibility Criteria
Inclusion
- Patients will be eligible for enrollment if they fulfill all of the following criteria:
- Metastatic colorectal cancer.
- Histologically or cytologically proven colorectal cancer.
- Expected survival of at least 4 months.
- Not more than 2 different pretreatment regimens.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Within the 2 weeks prior to the first dose of huA33, the following vital laboratory parameters:
- Lab Parameter Range
- Neutrophil count ≥ 1.5 x 10E9/L
- Platelet count ≥ 150 x 10E9/L
- Serum bilirubin ≤ 2 mg/dL
- Creatinine clearance \>50 ml/ min
- Age ≥ 18 years.
- Able and willing to give valid written informed consent.
Exclusion
- Patients will be excluded from the study for any of the following reasons:
- Untreated active metastatic disease to the central nervous system defined as new or enlarging lesions on CT or MRI.
- Surgery or radiotherapy of brain metastases within 3 months prior to the first dose of huA33.
- Metastatic disease involving \> 50% of liver volume.
- Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing (6 weeks for nitrosoureas).
- Previous treatment with oxaliplatin.
- Previous treatment with huA33 monoclonal antibody or antibody fragment.
- a. Positive huA33 HAHA titer - defined as greater than 3 standard deviations above the mean patient normal range by Biacore analysis.
- Concomitant treatment with systemic corticosteroids. Topical or inhalational corticosteroids are permitted.
- Known HIV, Hepatitis B or C positivity.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability of the patient for clinical and laboratory follow-up assessment.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
Key Trial Info
Start Date :
April 18 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00199797
Start Date
April 18 2005
End Date
April 1 2016
Last Update
October 10 2022
Active Locations (2)
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1
Krankenhaus Nordwest
Frankfurt, Germany, 60488
2
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091