Clinical trial · Interventional
Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
NCT00109863CI-TRIAL-00041746completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating patients with advanced melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hu14.18-IL2 fusion protein | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hu14.18-IL2 Treatment
- description
- Hu14.18-IL2 will be given on days 1, 2, and 3 of each course of therapy as a 4 hour continuous IV infusion at a daily dose of 6 mg/m2. Treatment courses will be repeated every 28 days at the same dose.
- interventionNames
- Biological: hu14.18-IL2 fusion protein
Primary outcomes (1)
- measure
- Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
Secondary outcomes (3)
- measure
- Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment
- measure
- Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Advanced disease * Measurable disease by clinical assessment or imaging * No known standard curative therapy exists * Disease no longer controlled by surgery, chemotherapy, or radiotherapy * No clinically detectable pleural effusion or ascites * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,500/mm\^3 OR * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL Hepatic * AST and ALT \< 2 times normal * Bilirubin \< 2.0 mg/dL * Hepatitis B surface antigen negative * No clinical evidence of hepatitis Renal * Creatinine \< 2.0 mg/dL OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No ischemic cardiac disease, congestive heart failure, or myocardial infarction within the past 6 months * No uncontrolled cardiac rhythm disturbance * No myocardial ischemia or heart failure by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age Pulmonary * Pulmonary function normal by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age Immunologic * HIV negative * No known hypersensitivity to the study drug, Tween-80®, or human immunoglobulin * No uncontrolled active infection Neurologic * No seizure disorder * No objective peripheral neuropathy ≥ grade 2 * No clinically significant neurologic deficit Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Must consent to the placement of a central venous line OR demonstrate stable peripheral IV access * Must be willing and able to discontinue antihypertensive medications (if advised to do so) on the days of study drug infusion * No uncontrolled active peptic ulcer * No known grade 4 side effects related to prior interleukin-2 * No diabetes mellitus that has required systemic therapy (e.g., oral hypoglycemic agents or insulin) within the past 3 months * No other significant illness * No significant psychiatric disability PRIOR CONCURRENT THERAPY: Biologic therapy * Prior monoclonal antibodies for biologic therapy, tumor imaging, purging of autologous bone marrow/stem cells for re-infusion, or for any other reason allowed provided there is documented absence of detectable antibody to hu14.18 by serology * No concurrent growth factors Chemotherapy * No immediate requirement for palliative chemotherapy * No concurrent anticancer chemotherapy Endocrine therapy * More than 2 weeks since prior and no concurrent corticosteroids (e.g., dexamethasone) * No immediate requirement for palliative hormonal therapy Radiotherapy * No immediate requirement for palliative radiotherapy * Concurrent palliative radiotherapy to localized painful lesions allowed provided ≥ 1 measurable or evaluable lesion is not irradiated AND the irradiated lesion is not used to assess tumor response Surgery * More than 3 weeks since prior major surgery * No prior organ allografts Other * More than 2 weeks since other prior and no concurrent immunosuppressive drugs * No prior standard or experimental systemic therapy for stage IV melanoma * No concurrent myelosuppressive antineoplastic drugs
References
Publications (0)
Data not yet available
No reference posted for this study.