Clinical trial · Interventional
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
A Phase III, Multi-Center Controlled Trial With Stratified Randomization Comparing The Efficacy Of Interleukin-2 (IL-2) Plus Histamine Dihydrochloride (HDC) Versus IL-2 Alone To Increase The Duration Of Survival In Patients With AJCC Stage IV Malignant Melanoma With Hepatic Metastasis
- 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: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver. PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.
Conditions
Conditions (2)
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 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| histamine dihydrochloride | Drug | Histamine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Must have radiological evidence of lesions in liver (target or non-target) * At least 1 measurable lesion outside previously irradiated field * At least 20 mm by contrast-enhanced CT scan, MRI, medical photography, or physical exam OR at least 10 mm by spiral CT scan * No prior or concurrent clinical and/or objective evidence of brain metastasis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * WHO 0-1 Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin at least 9.5 g/dL * WBC at least 3,000/mm\^3 * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 4 times ULN * Alkaline phosphatase no greater than 4 times ULN * Hepatitis B and C negative Renal: * Creatinine no greater than 1.7 mg/dL * Calcium no greater than 11.5 mg/dL Cardiovascular: * No abnormal thallium stress test * No acute myocardial infarction within the past year * No New York Heart Association class III or IV heart disease Pulmonary: * No asthma requiring active treatment within the past 5 years * Oxygen saturation by pulse oximeter at least 90% unless FEV\_1 is greater than 2 L or at least 75% predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * Concurrent medically-controlled (except with glyburide) or diet-controlled diabetes is allowed * Concurrent medically-controlled thyroid dysfunction is allowed * No other active malignancy within the past 5 years except carcinoma in situ of the cervix or localized squamous cell or basal cell skin cancer * No serious non-malignant medical conditions, including psychiatric disability, that would preclude study compliance * No active autoimmune disease (e.g., lupus, inflammatory bowel disease, or psoriasis) * No active peptic and/or esophageal ulcer disease * No hypersensitivity to histamine products or urticaria * No active IV drug abuse PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy with high-dose IV interleukin-2 (IL-2) * No prior combination immunotherapy with chemotherapy * At least 1 year since prior low-dose adjuvant IL-2 as part of vaccine therapy or as therapy for stage II or III melanoma Chemotherapy: * See Biologic therapy Endocrine therapy: * No chronic systemic glucocorticoid steroids * Asthma inhalers, topical creams, or intra-articular injections allowed * Hormonal therapy for non-melanoma-related conditions allowed Radiotherapy: * See Disease Characteristics * Concurrent radiotherapy as palliative therapy for isolated non-target lesions (e.g., bone lesions) allowed Surgery: * Not specified Other: * At least 4 weeks since prior therapy directed at malignancy * At least 4 weeks since prior investigational medications or therapies * At least 2 weeks since prior parenteral antioxidants and/or vitamins * At least 2 weeks since prior antibiotics for active illness * At least 2 weeks since prior H2 antagonists, beta-blockers, antihypertensives, antimalarials, antitrypanosomals, neuromuscular-blocking agents, tricyclic antidepressants, or alprazolam * At least 24 hours since prior antihistamines * No prior enrollment in any Maxim Pharmaceuticals investigational trials * No concurrent anticonvulsant therapy for seizure disorder * No other concurrent investigational drug * No concurrent H2 antagonists, tricyclic antidepressants, alprazolam, beta- blockers, antihypertensives, antitrypanosomals, antimalarials, or monoamine oxidase inhibitors * No concurrent inhibitors of diamine oxidase, monoamine oxidase, or histamine N-methyltransferase * No concurrent antihistamines
References
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