Cancer with metastasis
Conditions
Interventions
Trade Name: Zenapax
Product Name: Zenapax
Product Code: ?
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Simulect
Product Name: Simulect
Product Code: ?
Pharmaceutical
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histopathologically verified cancer with metastasis. No further conventional anti-cancer treatment options. Radiological visualisation of cancer/metastasis localisation must enable direct or ultrasonography mediated intratumoral injection Cancer diseases preferred: 1. liver, primary and secondary. 2. mammary cancer 3. sarcomas 4. melanomas 5. prostate 6. kidney, hypernefroma Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Expected lifetime 2 times upper normal value ASAT/ALAT >2 times upper normal value abnormal creatinine < 4 weeks from major surgery positive pregnancy test No use of safe barrier contraception Steroid treatment <4 weeks from start of CT Participation in other experimental treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe change of size of malignant tumor injected with Zenapax or Simulect;Secondary Objective: To observe change in number of regulatory T-lymphocytes in tumor assessed by PCR of transcripts primarily expressed in regulatory T-lymfocytes.;Primary end point(s): End of trial 3 months after last visit of last patient. | — |
Countries
Denmark
Outcome results
None listed