Status:
COMPLETED
111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen
Lead Sponsor:
Ludwig Institute for Cancer Research
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this clinical trial is to describe the toxicity, biodistribution, pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount of radioactive 111-Indium:...
Detailed Description
This clinical research study explores the activity of the new experimental antibody ch806 in humans for the first time. Cancers arising from an organ can be cured in some cases with various combinati...
Eligibility Criteria
Inclusion
- Patients with advanced or metastatic tumours which are positive for 806 antigen expression based on chromogenic in situ hybridization (CISH) or immuno-histochemistry (IHC) of archived tumour samples.
- Histologically or cytologically proven malignancy.
- Measurable disease on CT scan with at least one lesion \>/= 2 cm diameter (to allow adequate imaging).
- Age greater than or equal to 18 years.
- Karnofsky performance scale \>/= 70.
- Within the last 2 weeks vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Neutrophil count \>/= 1.5 x 10\^9/L; Platelet count \>/= 150 x 10\^9/L; Serum bilirubin \< 34 micromol/L; Creatinine clearance \> 50ml/min
- Able and willing to give valid written informed consent.
Exclusion
- Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (i.e. surgery or radiotherapy) for brain metastases. Primary central nervous system tumour (e.g. Glioblastoma Multiforme) is not an exclusion criterion.
- Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders.
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
- Clinically significant cardiac disease (New York Heart Association Class III/IV).
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Lack of availability for immunological and clinical follow-up assessments.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Women of childbearing potential: Refusal or inability to use effective means of contraception.
- Concomitant treatment with systemic corticosteroids except for patients with Glioblastoma. (Topical or inhalational corticosteroids are permitted.)
- Prior administration of monoclonal antibody or antibody fragment, and positive human anti-chimeric antibody (HACA) titre.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00291447
Start Date
May 1 2005
End Date
August 10 2006
Last Update
October 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ludwig Institute Tumor Targeting Program, Austin Health
Heidelberg, Victoria, Australia, 3084