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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.
- 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.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
aldesleukin, histamine dihydrochloride
Christie Hospital N.H.S. Trust
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:06-0400
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Drugs that bind to but do not activate histamine receptors, thereby blocking the actions of histamine or histamine agonists. Classical antihistaminics block the histamine H1 receptors only.
A class of histamine receptors discriminated by their pharmacology and mode of action. Histamine H3 receptors were first recognized as inhibitory autoreceptors on histamine-containing nerve terminals and have since been shown to regulate the release of several neurotransmitters in the central and peripheral nervous systems. (From Biochem Soc Trans 1992 Feb;20(1):122-5)
An enzyme that catalyzes the transfer of a methyl group from S-adenosylmethionine to histamine, forming N-methylhistamine, the major metabolite of histamine in man. EC 220.127.116.11.
A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.
Drugs that bind to and activate histamine receptors. Although they have been suggested for a variety of clinical applications histamine agonists have so far been more widely used in research than therapeutically.
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