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Interleukin-2 in Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT01702896
Recruitment Status : Terminated (PI Decision)
First Posted : October 10, 2012
Results First Posted : February 7, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

October 4, 2012
October 10, 2012
September 23, 2017
February 7, 2018
April 5, 2018
September 2012
December 2014   (Final data collection date for primary outcome measure)
Response Rate [ Time Frame: Measured until Disease Progression or death from any cause up to 2 years ]
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).
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 ]
Complete list of historical versions of study NCT01702896 on ClinicalTrials.gov Archive Site
  • Median Duration of Response [ Time Frame: Measured until Disease Progression or death from any cause up to 2 years ]
    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.
  • Median Survival [ Time Frame: From time of study entry until death, up to 10 years ]
    Measured from date of entry on study until date of death
  • 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 ]
Not Provided
Not Provided
 
Interleukin-2 in Metastatic Melanoma
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage
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).
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Melanoma Metastatic
Drug: Interleukin-2
Interleukin-2
Other Name: IL2
Experimental: Interleukin-2
Interleukin-2 will be used in this group
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.
 
Terminated
8
14
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01702896
12-07
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Western Regional Medical Center
Western Regional Medical Center
Not Provided
Study Director: Jordan Waypa, FNP Research Director
Western Regional Medical Center
April 2018

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