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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00004042
Registration number
NCT00004042
Ethics application status
Date submitted
10/12/1999
Date registered
20/08/2004
Date last updated
18/07/2013
Titles & IDs
Public title
Monoclonal Antibody F19 in Treating Patients With Advanced or Metastatic Cancer
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Scientific title
A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
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Secondary ID [1]
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MSKCC-98068
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Secondary ID [2]
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BOEH-1152.1
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - monoclonal antibody F19
Treatment: Other - iodine I 131 monoclonal antibody F19
Other interventions: monoclonal antibody F19
Treatment: Other: iodine I 131 monoclonal antibody F19
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically confirmed unresectable, advanced and/or metastatic
disease: Colorectal cancer Measurable or evaluable disease Epidemiologically proven
fibroblast activation protein positive Failed or refused conventional treatment, and
unlikely to derive significant benefit from conventional treatments No active CNS
metastases No new or progressive lesions on CT scan, more than 3 months since treatment
(i.e., surgery or radiotherapy) for brain metastases, and/or not receiving mitomycin
Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance
status: Karnofsky 70-100% Life expectancy: At least 4 months Hematopoietic: Absolute
granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: ALT/AST
no greater than 3 times upper limit of normal Bilirubin less than 2 mg/dL Renal: Creatinine
no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use
effective contraception No other serious illness No active infections requiring antibiotics
No bleeding disorders No other diseases that may potentially interfere with obtaining
accurate study results
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
prior murine, chimeric or humanized antibody and/or antibody fragment Chemotherapy: See
Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas
and mitomycin) Endocrine therapy: No concurrent systemic corticosteroids (except for acute
management of allergic-type events) No concurrent immunosuppressive agents Radiotherapy:
See Disease Characteristics Surgery: See Disease Characteristics Recovered from surgery
Other: At least 4 weeks since other prior investigational agents
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/1998
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2009
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Sample size
Target
24
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Ludwig Institute for Cancer Research-Sydney Branch - Sydney
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Recruitment postcode(s) [1]
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2006 - Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Minnesota
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Country [2]
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United States of America
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State/province [2]
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New York
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Funding & Sponsors
Primary sponsor type
Other
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Name
Memorial Sloan Kettering Cancer Center
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody F19 in treating
patients who have advanced or metastatic cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00004042
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sydney Welt, MD
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Address
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Memorial Sloan Kettering Cancer Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00004042
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