search
Back to results

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

Primary Purpose

Kidney Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
aldesleukin
histamine dihydrochloride
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer, recurrent renal cell cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
September 19, 2013
Sponsor
The Christie NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT00005038
Brief Title
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2001
Overall Recruitment Status
Unknown status
Study Start Date
June 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer, recurrent renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Drug
Intervention Name(s)
histamine dihydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Middleton, MD, PhD, MBChB, MRCP
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 9BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs