Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. (SBRT/IL-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Providence Health & Services
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01416831
First received: August 12, 2011
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.


Condition Intervention Phase
Metastatic Melanoma
Other: Radiation therapy and high-dose IL-2
Drug: High-dose IL-2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Response rate in crossover patients [ Time Frame: 7 weeks following IL-2 course that was preceded by radiation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 44
Study Start Date: July 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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 radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of 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 1-20 who are assigned to receive radiation therapy will receive a single dose of radiation before IL-2; patients 21-44 assigned to receive radiation will receive two doses of radiation before receiving high-dose IL-2.
Other: Radiation therapy and high-dose IL-2
Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
Other Names:
  • Interleukin 2
  • Stereotactic Body Radiation Therapy (SBRT)

Detailed Description:

All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT01416831

Contacts
Contact: Christopher Fountain, R.N. 503-215-2691 christopher.fountain@providence.org
Contact: Brenda Fisher, R.N. 503-215-2613 brenda.fisher@providence.org

Locations
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Contact: Chris Fountain, RN       christopher.fountain@providence.org   
Sub-Investigator: Walter J. Urba, M.D., Ph.D         
Sub-Investigator: Rachel Sanborn, MD         
Sub-Investigator: Todd Crocenzi, MD         
Sub-Investigator: Robert Lufkin, MD         
Sub-Investigator: Roxanne Payne, FNP         
Sub-Investigator: Bernard Fox, Ph.D         
Sub-Investigator: Michael Gough, Ph.D.         
Sub-Investigator: Edwin Walker, Ph.D.         
Sub-Investigator: John W. Smith, MD         
Sub-Investigator: Stephen Bader, MD         
Sub-Investigator: Alice Wang-Chesebro, MD         
Sub-Investigator: Matthew Solhjem, MD         
Sponsors and Collaborators
Providence Health & Services
Prometheus Laboratories
Investigators
Principal Investigator: Brendan Curti, M.D. Providence Health & Services
Principal Investigator: Steven K. Seung, M.D. Providence Health & Services
Principal Investigator: Marka Crittenden, MD, PhD Providence Health & Services
  More Information

Additional Information:
No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01416831     History of Changes
Other Study ID Numbers: 11-062A
Study First Received: August 12, 2011
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Providence Health & Services:
metastatic melanoma
IL-2
Interleukin 2
Radiation
Stereotactic Body Radiation Treatment
SBRT

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

ClinicalTrials.gov processed this record on October 23, 2014