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Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: February 6, 2009   History of Changes
Sponsored by: Christie Hospital NHS Foundation Trust
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005038
  Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients with metastatic kidney cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Drug: histamine dihydrochloride
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Interleukin-2 Aldesleukin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma

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

Study Start Date: June 1999
Detailed Description:

OBJECTIVES:

  • Determine the clinical efficacy and safety of subcutaneous (SC) histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year, objective tumor response rate, duration of response, and median survival.

OUTLINE: This is a randomized, open label study. Patients are randomized to receive interleukin-2 (IL-2) with or without histamine dihydrochloride.

  • Arm I: Patients receive IL-2 subcutaneously (SC) once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest.
  • Arm II: Patients receive IL-2 as in arm I. Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma
  • Bidimensionally measurable disease
  • No clinical evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin greater than 10.0 g/dL
  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • PTT normal
  • Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No abnormal cardiac function by resting ECG

Pulmonary:

  • FEV and FVC at least 70% predicted
  • SaO2 at least 90% by pulse oximetry

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No clinically significant acute viral, bacterial, or fungal infection requiring specific therapy
  • No pheochromocytoma
  • No glaucoma
  • No other concurrent ongoing active malignancy except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin
  • No serious recent nonmalignant medical complication that would preclude study therapy
  • No organ grafts except skin grafts, blood transfusions, or bone marrow or stem cell transplantation
  • No prior documented asthma or systemic allergic reaction within past 5 years
  • No history of seizures, CNS disorders, or psychiatric disability that would preclude study compliance
  • No medical, sociologic, or psychological impediment that would preclude study compliance
  • No active peptic or esophageal ulcer disease
  • No prior peptic or esophageal ulcer disease with history of bleeding
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 24 hours since prior steroids
  • No concurrent steroids including steroid therapy for documented adrenal failure or septic shock
  • Concurrent noncorticosteroid hormones for nonmalignancy conditions allowed

Radiotherapy:

  • At least 4 weeks since prior extensive radiotherapy
  • No concurrent radiotherapy to measurable malignant masses

Surgery:

  • Not specified

Other:

  • At least 24 hours since prior beta blockers or clonidine
  • No other concurrent systemic antimalignancy therapy
  • No other concurrent antitumor agents
  • No other concurrent investigational agents
  • No concurrent beta blockers or clonidine
  • No concurrent H2 receptor antagonists (e.g., Zantac, Tagamet) (arm I only)
  • No concurrent antihistamines except to treat acute colds or allergy symptoms
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005038

Locations
United Kingdom, England
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 9BX
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Mark R. Middleton, MD, PhD, MBChB, MRCP Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067627, CHNT-IL2-MAXAMINE, EU-99048, MAXIM-MP-502
Study First Received: April 6, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00005038     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Neurotransmitter Agents
Kidney Cancer
Anti-HIV Agents
Urogenital Neoplasms
Urologic Neoplasms
Antiviral Agents
Recurrence
Histamine
Carcinoma
Aldesleukin
Renal Cancer
Anti-Retroviral Agents
Urologic Diseases
Analgesics, Non-Narcotic
Interleukin-2
Kidney Neoplasms
Carcinoma, Renal Cell
Histamine phosphate
Peripheral Nervous System Agents
Analgesics
Kidney Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Urologic Diseases
Sensory System Agents
Kidney Neoplasms
Therapeutic Uses
Analgesics
Kidney Diseases
Anti-HIV Agents
Neoplasms by Histologic Type
Histamine Agents
Antiviral Agents
Pharmacologic Actions
Histamine
Carcinoma
Neoplasms
Aldesleukin
Histamine Agonists
Interleukin-2
Analgesics, Non-Narcotic
Carcinoma, Renal Cell
Histamine phosphate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009