Interleukin-2 in Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified October 2012 by Western Regional Medical Center
Sponsor:
Western Regional Medical Center
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01702909
First received: October 4, 2012
Last updated: October 25, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Cancer Metastatic Kidney Cancer Metastatic |
Drug: Interleukin-2 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Kidney Cancer |
Resource links provided by NLM:
Further study details as provided by Western Regional Medical Center:
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: | 35 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Interleukin-2
Interleukin-2
|
Drug: Interleukin-2
Interleukin-2
Other Name: IL2
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702909
Contacts
| Contact: Marci Pierog, RN | 623-207-3818 | marci.pierog@ctca-hope.com |
| Contact: India Hill, CCRP | 623-207-3392 | india.hill@ctca-hope.com |
Locations
| United States, Arizona | |
| Western Regional Medical Center, Inc | Recruiting |
| Goodyear, Arizona, United States, 85338 | |
| Contact: Marci Pierog, RN 623-207-3000 marci.pierog@ctca-hope.com | |
| Contact: India Hill, CCRP 623 207-3000 india.hill@ctca-hope.com | |
| Principal Investigator: Walter Quan, MD | |
Sponsors and Collaborators
Western Regional Medical Center
Investigators
| Principal Investigator: | Walter Quan, MD | Western Regional Medical Center |
More Information
No publications provided
| Responsible Party: | Walter Quan Jr., MD, Principal Investigator, Western Regional Medical Center |
| ClinicalTrials.gov Identifier: | NCT01702909 History of Changes |
| Other Study ID Numbers: | 12-08 |
| Study First Received: | October 4, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Western Regional Medical Center:
|
Metastatic Renal Cell Metastatic Kidney Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Neoplasms Neoplasms, Second Primary Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013