Trials / Unknown
UnknownNCT00005038
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- The Christie NHS Foundation Trust · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | aldesleukin | |
| DRUG | histamine dihydrochloride |
Timeline
- Start date
- 1999-06-01
- First posted
- 2003-01-27
- Last updated
- 2013-09-20
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00005038. Inclusion in this directory is not an endorsement.