Melanoma Metastatic Clinical Trial
Official title:
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma
Verified date | April 2018 |
Source | Western Regional Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage
Status | Terminated |
Enrollment | 8 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients must have a histologic diagnosis of metastatic melanoma. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Western Regional Medical Center, Inc. | Goodyear | Arizona |
Lead Sponsor | Collaborator |
---|---|
Western Regional Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2). | Measured until Disease Progression or death from any cause up to 2 years | |
Secondary | Median Duration of Response | Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions. | Measured until Disease Progression or death from any cause up to 2 years | |
Secondary | Median Survival | Measured from date of entry on study until date of death | From time of study entry until death, up to 10 years |
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