- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005038
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
-
Manchester, England, United Kingdom, M20 9BX
- Christie Hospital N.H.S. Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: Mark R. Middleton, MD, PhD, MBChB, MRCP, The Christie NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Histamine Agents
- Histamine Agonists
- Aldesleukin
- Histamine
- Histamine phosphate
Other Study ID Numbers
- CDR0000067627
- CHNT-IL2-MAXAMINE
- EU-99048
- MAXIM-MP-502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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