Interleukin-2 in Metastatic Melanoma
Verified January 2014 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: January 9, 2014
Last verified: January 2014
The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used in this study will help to increase tumor shrinkage
||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 Melanoma
Primary Outcome Measures:
- Progression free survival of patients with metastatic melanoma who have had disease progression on at least one prior systemic therapy or has 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:
||December 2014 (Final data collection date for primary outcome measure)
Other Name: IL2
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma 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 melanoma. 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702896
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
||January 9, 2014
||United States: Institutional Review Board
Keywords provided by Western Regional Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents