Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00139360
Eligibility Criteria:
LEVEL A (second line): after confirmed progression on standard first line treatment with dacarbazine.
LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients will be included for first line treatment with bevacizumab
Inclusion Criteria:
* Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
* WHO performance status 0-2
* Age \>18 years
* Able to undergo outpatient treatment
* Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
* At least 4 weeks since adjuvant interferon alpha
* Recovered from prior chemotherapy
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
* Minimum required laboratory data:
Hematology: absolute granulocytes \> 1.0 x 109/L platelets \> 100 x 109/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.
Exclusion Criteria:
* No pregnant or lactating patients can be included
* No prior interferon alpha or IL-2 for metastatic disease
* No more than 1 prior chemotherapy regimen for metastatic disease
* No clinical evidence of coagulopathy
* No brain metastases
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No history of thrombosis
* No full-dose oral coumarin-derived anticoagulants (INR\>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (\>325 mg/day)
* No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
* No uncontrolled hypertension
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00139360
Study Brief:
Protocol Section:
NCT00139360