NCT00005038

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 20, 2013

Status Verified

June 1, 2001

First QC Date

April 6, 2000

Last Update Submit

September 19, 2013

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

aldesleukinBIOLOGICAL
histamine dihydrochlorideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Christie Hospital N.H.S. Trust

Manchester, England, M20 9BX, United Kingdom

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

aldesleukinHistamine

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Mark R. Middleton, MD, PhD, MBChB, MRCP

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

January 27, 2003

Study Start

June 1, 1999

Last Updated

September 20, 2013

Record last verified: 2001-06

Locations

GB(1)