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Sponsored by: |
Christie Hospital NHS Foundation Trust |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005038 |
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 |
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 |
Study Start Date: | June 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, open label study. Patients are randomized to receive interleukin-2 (IL-2) with or without histamine dihydrochloride.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 9BX |
Study Chair: | Mark R. Middleton, MD, PhD, MBChB, MRCP | Christie Hospital NHS Foundation Trust |
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 |
stage IV renal cell cancer recurrent renal cell cancer |
Urinary Tract Neoplasm Anti-Infective Agents Neurotransmitter Agents Urogenital Neoplasms Urologic Neoplasms Renal Cancer Urologic Diseases Anti-Retroviral Agents Kidney Neoplasms Kidney Diseases Analgesics Kidney Cancer Anti-HIV Agents |
Antiviral Agents Recurrence Carcinoma Histamine Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Histamine phosphate Peripheral Nervous System Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |
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 |