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Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005038
Recruitment Status : Unknown
Verified June 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Cancer Biological: aldesleukin Drug: histamine dihydrochloride Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 1999

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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



  • 18 to 75

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


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


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


  • Creatinine less than 1.5 times ULN


  • No abnormal cardiac function by resting ECG


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


  • 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


Biologic therapy:

  • At least 4 weeks since prior immunotherapy


  • 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


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


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005038

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United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 9BX
Sponsors and Collaborators
The Christie NHS Foundation Trust
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Study Chair: Mark R. Middleton, MD, PhD, MBChB, MRCP The Christie NHS Foundation Trust
Layout table for additonal information Identifier: NCT00005038    
Other Study ID Numbers: CDR0000067627
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: June 2001
Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer
Additional relevant MeSH terms:
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Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Histamine phosphate
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs