Trial record 1 of 3 for:
Interleukin-2 in Metastatic Melanoma quan
Interleukin-2 in Metastatic Melanoma
This study has been terminated.
First Posted: October 10, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
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
||Intervention Model: Single Group Assignment
Masking: None (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 ]
Secondary Outcome Measures:
- Response rate [ Time Frame: 9 weeks ]
- Median duration of response [ Time Frame: 9 weeks ]
- Median survival of patients treated with this moderate dose bolus Interleukin-2 schedule. [ Time Frame: 9 weeks ]
| Study Start Date:
| Study Completion Date:
| 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).
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|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702896
|Western Regional Medical Center, Inc.
|Goodyear, Arizona, United States, 85338 |
Western Regional Medical Center
||Walter Quan, MD
||Western Regional Medical Center
||Walter Quan Jr., MD, Principal Investigator, Western Regional Medical Center
History of Changes
|Other Study ID Numbers:
||October 4, 2012
||October 10, 2012
|Last Update Posted:
||October 12, 2017
Keywords provided by Walter Quan
Jr., MD, Western Regional Medical Center:
Additional relevant MeSH terms:
Nevi and Melanomas
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs