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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039234
First received: June 6, 2002
Last updated: December 17, 2013
Last verified: December 2003
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Metastatic Cancer
Biological: aldesleukin
Drug: histamine dihydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Compare the duration of survival in patients with stage IV melanoma with hepatic metastasis treated with interleukin-2 with or without histamine dihydrochloride.
  • Compare the progression-free survival, response rate, response rate of hepatic tumors, and lack of disease progression in patients treated with these regimens.
  • Determine the safety of these regimens, in terms of frequency, severity, and causal relationship of adverse events, in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center location (North America vs Europe), lactate dehydrogenase (less than ULN vs ULN or greater), and metastatic sites (liver only vs liver and other sites). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive interleukin-2 (IL-2) subcutaneously (SC) twice daily on days 1 and 2 of weeks 1 and 3 and days 1-5 of weeks 2 and 4. Patients also receive histamine dihydrochloride SC over 10-30 minutes on days 1-5 of weeks 1-4.
  • Arm II: Patients receive IL-2 as in arm I. In both arms, treatment repeats every 6 weeks for at least 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 224 patients (112 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039234

Locations
United States, California
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, Florida
Moffitt Clinic at Tampa General Hospital
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Melanoma Center of St. Louis, Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
United States, New York
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
Beth Israel Medical Center
New York, New York, United States, 10003
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Germany
Charite - Universitaetsmedizin Berlin
Berlin, Germany, D-12200
Universitatsklinik - Saarland
Homburg/Saar, Germany, D-66421
Kiel Universitatshautklinik
Kiel, Germany, DOH-24105
Klinische Kooperationseinheit fur Dermatoonkologie (DFKZ)
Mannheim, Germany, 68135
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich, Germany, D-81675
United Kingdom
Royal Marsden Hospital - Sutton
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Maxim Pharmaceuticals
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039234     History of Changes
Other Study ID Numbers: CDR0000069365, MAXIM-MP-8899-0104, UCLA-0111056, NCI-G02-2070, MSKCC-03057
Study First Received: June 6, 2002
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma
liver metastases

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Histamine
Histamine phosphate
Aldesleukin
Interleukin-2
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antineoplastic Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014