Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maxim Pharmaceuticals
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Histamine; Histamine phosphate; Interleukin-2

Criteria

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