Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00005038
• Other study ID #: CDR0000067627
• Secondary ID: CHNT-IL2-MAXAMIN
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: September 19, 2013
• Start date: June 1999

Study information

• Verified date: June 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• aldesleukin

Drug:
• histamine dihydrochloride

Locations

Country	Name	City	State
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England

Sponsors (1)

Lead Sponsor	Collaborator
Christie Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom,