111-In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 12
• Participant gender: Both

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: 111In-ch806) in patients with advanced tumours expressing the 806 antigen.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Last Updated: 2006-08-11

Criteria

Inclusion Criteria:

• Patients with advanced or metastatic tumours which are positive for 806 antigen expression based on CISH or 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).

• 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 Criteria:

• 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, eg, 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.