Interleukin-2 in Metastatic Melanoma

This study is currently recruiting participants.
Verified January 2014 by Western Regional Medical Center
Sponsor:
Information provided by (Responsible Party):
Walter Quan Jr., MD, Western Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01702896
First received: October 4, 2012
Last updated: January 9, 2014
Last verified: January 2014

October 4, 2012
January 9, 2014
September 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01702896 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Interleukin-2 in Metastatic Melanoma
Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma

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

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma Metastatic
Drug: Interleukin-2
Interleukin-2
Other Name: IL2
Experimental: Interleukin-2
Interleukin-2
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.
 
Recruiting
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.
Both
18 Years and older
No
Not Provided
United States
 
NCT01702896
12-07
No
Walter Quan Jr., MD, Western Regional Medical Center
Western Regional Medical Center
Not Provided
Principal Investigator: Walter Quan, MD Western Regional Medical Center
Western Regional Medical Center
January 2014

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