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Interleukin-2 in Metastatic Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01702909
First received: October 4, 2012
Last updated: January 9, 2014
Last verified: January 2014

October 4, 2012
January 9, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01702909 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Interleukin-2 in Metastatic Kidney Cancer
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer

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.

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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Cancer Metastatic
  • Kidney Cancer Metastatic
Drug: Interleukin-2
Interleukin-2
Other Name: IL2
Experimental: Interleukin-2
Interleukin-2
Intervention: Drug: Interleukin-2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may have received prior systemic therapy or may be previously untreated
  2. Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
  3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
  4. 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.
  5. 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.
  6. Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
  7. Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
  8. Patient consent must be obtained prior to entrance onto study.
  9. Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment

Exclusion Criteria:

  1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
  2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
  3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
  4. Lactation or pregnancy.
  5. 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.
  6. Current brain metastasis.
Both
18 Years and older
No
Contact: Marci Pierog, RN 623-207-3818 marci.pierog@ctca-hope.com
Contact: India Hill, CCRP 623-207-3392 india.hill@ctca-hope.com
United States
 
NCT01702909
12-08
No
Walter Quan Jr., MD, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Walter Quan, MD Western Regional Medical Center
Western Regional Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP