Please note that IPD sharing statement and summary results sections will be added to the ANZCTR form in the coming months in order to comply with the updated WHO Trial Registration Data Set.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00004042




Trial ID
NCT00004042
Ethics application status
Date submitted
10/12/1999
Date registered
19/08/2004
Date last updated
17/07/2013

Titles & IDs
Public title
Monoclonal Antibody F19 in Treating Patients With Advanced or Metastatic Cancer
Scientific title
A Phase I Dose-Escalation Study of BIBH-1 in Patients With Advanced or Metastatic Fibroblast Activation Protein-Positive Cancer
Secondary ID [1] 0 0
MSKCC-98068
Secondary ID [2] 0 0
BOEH-1152.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Ludwig Institute for Cancer Research-Sydney Branch - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
Memorial Sloan Kettering Cancer Center
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00004042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sydney Welt, MD
Address 0 0
Memorial Sloan Kettering Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries