EUCTR2009-014799-23-AT
Active, not recruiting
Not Applicable
A phase II study of intratumoral application of L19IL2 in patients with stage III/IV melanoma - L19IL2 intratumoral
Philogen S.p.A0 sites40 target enrollmentMarch 3, 2011
ConditionsCancer- Patients with histopathologically-proven malignant melanoma with presence of measurable and injectable dermal or subcutaneous metastases either in clinical stage III or stage IVMedDRA version: 15.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer- Patients with histopathologically-proven malignant melanoma with presence of measurable and injectable dermal or subcutaneous metastases either in clinical stage III or stage IV
- Sponsor
- Philogen S.p.A
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histopathologically proven malignant melanoma
- •Presence of measurable and injectable soft tissue metastases either in clinical stage III or stage IV M1a without visceral metastases
- •Males or females, age \> 18 years
- •Either without or after one line of prior systemic treatment for metastatic disease.
- •ECOG performance status \< 2
- •LDH \< 2 x the upper limit of normal
- •Life expectancy of at least 12 weeks
- •Absolute neutrophil count \> 1\.5 x 109/L, hemoglobin \> 9\.0 g/dL and platelets \> 100 x 109/L
- •Negative serum pregnancy test (for women of child\-bearing potential only) at screening
- •If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug.
Exclusion Criteria
- •Primary ocular melanoma
- •Presence of visceral metastases at screening
- •Evidence of active brain metastases at screening.
- •History of HIV infection or infectious hepatitis B or C
- •Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- •Inadequately controlled cardiac arrhythmias including atrial fibrillation
- •Heart insufficiency (\> Grade II, New York Heart Association (NYHA) criteria)
- •Uncontrolled hypertension
- •Ischemic peripheral vascular disease (Grade IIb\-IV)
- •Active autoimmune disease
Outcomes
Primary Outcomes
Not specified
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