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History of Changes for Study: NCT01416831
Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)
Latest version (submitted September 23, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 12, 2011 None (earliest Version on record)
2 July 13, 2012 Sponsor/Collaborators, Study Status and Contacts/Locations
3 March 6, 2013 Study Status, Contacts/Locations, Arms and Interventions, Study Description and Study Identification
4 December 16, 2013 Study Status
5 October 14, 2014 Study Status
6 April 27, 2015 Contacts/Locations and Study Status
7 March 28, 2016 Study Status and IPDSharing
8 June 23, 2016 Study Status and Conditions
9 September 18, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 January 16, 2018 Study Status
11 September 25, 2019 Study Status
12 September 23, 2021 Study Status
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Study NCT01416831
Submitted Date:  August 12, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: 110-062A
Brief Title: Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)
Official Title: Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2011
Overall Status: Recruiting
Study Start: July 2011
Primary Completion: July 2012 [Anticipated]
Study Completion: December 2012 [Anticipated]
First Submitted: August 12, 2011
First Submitted that
Met QC Criteria:
August 12, 2011
First Posted: August 15, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 12, 2011
Last Update Posted: August 15, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Providence Health & Services
Responsible Party:
Collaborators: Prometheus Laboratories
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL2 to patients treated with high-dose IL2 along with radiation therapy.
Detailed Description: All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive a single dose of radiation therapy to up to three tumors prior to receiving high-dose IL-2.
Open or close this module Conditions
Conditions: Metastatic Melanoma
Keywords: metastatic melanoma
IL-2
Interleukin 2
Radiation
Stereotactic Body Radiation Treatment
SBRT
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 44 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: High-dose IL-2
Patients receive standard high-dose IL-2 therapy, with an opportunity to crossover to the experimental arm if there is disease progression noted after two cycles of high-dose IL-2.
Drug: High-dose IL-2
IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive a single fraction of radiation (20 Gy)given on a Friday before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.
Other Names:
  • Interleukin 2
  • Stereotactic Body Radiation Therapy (SBRT).
Experimental: Radiation therapy and high-dose IL-2
Patients will receive a single dose of radiation before receiving high-dose IL-2.
Radiation therapy and high-dose IL-2
Patients will receive a single fraction of radiation. The dose for all patients will be 20 Gy per fraction delivered on a Friday before the first dose of IL-2 administration. IL-2 shall commence on the Monday following completion of radiation, administered at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be administered during two cycles (one course) will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2, but no further radiation is given.
Other Names:
  • Interleukin 2
  • Stereotactic Body Radiation Therapy (SBRT)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in diameter of target lesions
[ Time Frame: Within 28 days of starting treatment, after one course of IL-2 (7 weeks), and after each subsequent course of IL-2 (Weeks 14 and 21) ]

All measurable lesions up to a maximum of five lesions per organ and 10 lesions in total, representative of all involved organs, will be identified as target lesions and recorded and measured at baseline. Target lesions will be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the baseline, which will be used as reference by which to characterize the objective tumor response.
Secondary Outcome Measures:
1. Response rate in crossover patients
[ Time Frame: 7 weeks following IL-2 course that was preceded by radiation ]

Measure the response rate of patients with metastatic melanoma who receive radiation and high-dose IL-2 who had disease progression after high-dose IL-2.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histological confirmation of melanoma will be required by previous biopsy or cytology.
  • Patients must be ≥ 18 years of age.
  • Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated.
  • ECOG performance status of 0-1.
  • Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
  • Patients must sign a study-specific consent form.

Exclusion Criteria:

  • No metastatic site amenable to SBRT.
  • Patients with brain metastases not candidates for radiosurgery.
  • Previous radiation to sites proposed for radiation as part of this study.
  • Patients with active systemic, pulmonary, or pericardial infection.
  • Pregnant or lactating women.
  • Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG.
  • DLCO, FEV1 or FEV1/FVC less than 70% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high dose IL-2 therapy.
  • WBC < 3.0 x 109/L
  • Hgb < 9.0 g/dL
  • AST/ALT > 3 times the upper limit of the normal range
  • total bilirubin > 1.9 g/dL
  • creatinine > 1.9 g/dL
  • Patient requires chronic steroids.
Open or close this module Contacts/Locations
Central Contact Person: Christopher Fountain, R.N.
Telephone: 503-215-2691
Email: christopher.fountain@providence.org
Central Contact Backup: Brenda Fisher, R.N.
Telephone: 503-215-2613
Email: brenda.fisher@providence.org
Study Officials: Brendan Curti, M.D.
Principal Investigator
Providence Health & Services
Steven K. Seung, M.D.
Principal Investigator
Providence Health & Services
Locations: United States, Oregon
Providence Cancer Center
[Recruiting]
Portland, Oregon, United States, 97213
Contact:Contact: Fountain christopher.fountain@providence.org
Contact:Sub-Investigator: Marka Crittenden, MD
Contact:Sub-Investigator: Walter J. Urba, M.D., Ph.D
Contact:Sub-Investigator: Rachel Sanborn, MD
Contact:Sub-Investigator: Eric Bernstein, MD
Contact:Sub-Investigator: Todd Crocenzi, MD
Contact:Sub-Investigator: Robert Lufkin, MD
Contact:Sub-Investigator: Roxanne Payne, FNP
Contact:Sub-Investigator: Bernard Fox, Ph.D
Contact:Sub-Investigator: Michael Gough, Ph.D.
Contact:Sub-Investigator: Edwin Walker, Ph.D.
Contact:Sub-Investigator: John W. Smith, MD
Contact:Sub-Investigator: Stephen Bader, MD
Contact:Sub-Investigator: Alice Wang-Chesebro, MD
Contact:Sub-Investigator: Matthew Solhjem, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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