Interleukin-2 in Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified October 2012 by Western Regional Medical Center
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
First received: October 4, 2012
Last updated: October 25, 2012
Last verified: October 2012
The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help increase tumor shrinkage.
Renal Cell Cancer Metastatic
Kidney Cancer Metastatic
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer
Primary Outcome Measures:
- Progression free survival of patients with metastatic kidney cancer who have had disease progression on at least one prior therapy or who have not been treated. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Median duration of response [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Median survival of patients treated with this moderate dose bolus Interleukin-2 schedule. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Other Name: IL2
In this phase II study, the IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a cohort of kidney cancer patients to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (> 1440 million IU/m2/year).
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
- Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
- ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
- Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
- Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
- Patient consent must be obtained prior to entrance onto study.
- Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
- Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
- Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
- Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
- Lactation or pregnancy.
- Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
- Current brain metastasis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702909
Western Regional Medical Center
||Walter Quan, MD
||Western Regional Medical Center
No publications provided
||Walter Quan Jr., MD, Principal Investigator, Western Regional Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 4, 2012
||October 25, 2012
||United States: Institutional Review Board
Keywords provided by Western Regional Medical Center:
Metastatic Renal Cell
Metastatic Kidney Cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Carcinoma, Renal Cell
Neoplasms, Second Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents