Depletion of regulatory T-lymphocytes by intratumoral injection of antibodies.

Phase 1

• Conditions: Cancer with metastasis

• Registration Number: EUCTR2005-003997-74-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-10
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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

Expected lifetime < 3 months
ECOG 3-4.
Ongoing infection
< 4 weeks from prior immunosuppressive therapy
Billirubin >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified