Interleukin-2 in Metastatic Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014