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
  Purpose

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


Condition Intervention Phase
Melanoma Metastatic
Drug: Interleukin-2
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Western Regional Medical Center:

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: 14
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin-2
Interleukin-2
Drug: Interleukin-2
Interleukin-2
Other Name: IL2

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702896

Locations
United States, Arizona
Western Regional Medical Center, Inc. Recruiting
Goodyear, Arizona, United States, 85338
Contact: Marci Pierog, RN    623-207-3000    marci.pierog@ctca-hope.com   
Contact: India Hill, CCRP    623 207-3000    india.hill@ctca-hope.com   
Principal Investigator: Walter Quan, MD         
Sponsors and Collaborators
Western Regional Medical Center
Investigators
Principal Investigator: Walter Quan, MD Western Regional Medical Center
  More Information

No publications provided

Responsible Party: Walter Quan Jr., MD, Principal Investigator, Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01702896     History of Changes
Other Study ID Numbers: 12-07
Study First Received: October 4, 2012
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Western Regional Medical Center:
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014