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Also known as Interleukin-2, IL-2, Aldesleukin, Proleukin
HDIL-2 · 1 trial · 1 indication
To evaluate the objective response rate induced by the concurrent administration of HDIL-2 and recMAGE-A3 + AS15 ASCI in patients with MAGE-A3-positive, unresectable or metastatic melanoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| HDIL-2 + recMAGE-A3 + AS15 | EXPERIMENTAL | HDIL-2 720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle. recMAGE-A3 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2. |
| Name | Type | Description |
|---|---|---|
| HDIL-2 | DRUG | 720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle. |
| recMAGE-A3 + AS15 | BIOLOGICAL | 300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2. |
Inclusion Criteria: 1. STEP 1 Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure. 2. Male or female patient with histologically proven, measurable unresectable or metastatic cutaneous melanoma 3. Patient is \>/= 18 years of age. 4. ...
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