Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| histamine dihydrochloride | Drug | Histamine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
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