Identification of biological effects of bevacizumab in surgically resectable melanoma tumors.

Phase 2

• Conditions: melanoma cancer; skin cancer; 10040900

• Registration Number: NL-OMON30987
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Surgically resectable melanoma.
• WHO performance status 0-2.
• Age >18 years.
• Minimum required laboratory data:
• Hematology: Leucocytes 4,0-10,0x109/l.
• Biochemistry: bilirubin < 1.5 x upper normal limit. Serum creatinine within normal limits INR < 1.5.
• Before patient registration/randomization, written informed consent must be given according to national and local regulations.
• Able to comply with the protocol

Exclusion Criteria

• Prior chemotherapy or biological therapy for metastatic disease.
• Prior radiotherapy on the involved area.
• Major surgery within 28 days before the initiation of the study.
• Clinically significant cardiovascular disease.
• Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
• CNS metastases (CT-Scan not mandatory).
• Treatment with any investigational drug within 30 days before the start of the study.
• Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety assessments will consist of evaluating labatory parameters and adverse<br /><br>events according to NCI CTCAE 3.0.<br /><br>The following variables will be analyzed to assess the effectiveness of<br /><br>bevacizumab in the treatment of melanoma tumors:<br /><br>• Biological parameters.<br /><br>• Histopathological parameters.<br /><br>• 111In-bevacizumab distribution kinetics by gamma-camera imaging. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>