Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
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ClinicalTrials.gov 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
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Kidney Cancer | Biological: aldesleukin Drug: histamine dihydrochloride | Phase 2 |
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 : | 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 |


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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 |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00005038
United Kingdom | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 9BX |
Study Chair: | Mark R. Middleton, MD, PhD, MBChB, MRCP | The Christie NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00005038 History of Changes |
Other Study ID Numbers: |
CDR0000067627 CHNT-IL2-MAXAMINE EU-99048 MAXIM-MP-502 |
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:
Kidney Neoplasms Carcinoma, Renal Cell Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Kidney Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Aldesleukin Interleukin-2 Histamine |
Histamine phosphate Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Histamine Agonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |