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Trial record 1 of 1 for:    NCT01970527
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Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

This study is currently recruiting participants.
Verified August 2017 by University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970527
First Posted: October 28, 2013
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
  Purpose
This phase II trial studies how well stereotactic body radiotherapy and ipilimumab work in treating patients with stage IV melanoma. Stereotactic body radiotherapy (SBRT) may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, target certain cells to interfere with the ability of tumor cells to grow and spread. Giving SBRT with ipilimumab may kill more tumor cells.

Condition Intervention Phase
Recurrent Melanoma Stage IV Skin Melanoma Biological: Ipilimumab Other: Laboratory Biomarker Analysis Other: Pharmacological Study Radiation: Stereotactic Body Radiation Therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Immune-related clinical response, defined as proportion of patients treated at the maximum-tolerated dose (MTD) who achieve either a complete or partial immune-related response [ Time Frame: Up to 60 days after last ipilimumab injection ]
    Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1. The number of immune-related responses will be tabled by stratum and SBRT fraction dose level. At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients.

  • Immune-related progression-free survival (irPFS) [ Time Frame: Time from first day of radiotherapy to first documented immune-related progressive disease, death due to any cause or last patient contact alive and progression-free, assessed at 6 months ]
    irPFS will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.

  • Late toxicities, graded according to the Radiation Therapy Oncology Group/European Organization for Research, the Treatment of Cancer late morbidity scoring system, and the Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ]
    Defined generally as an adverse event associated with the treatment which occurs beyond 30 days after last injection (i.e., adverse events which are observed months after treatment are most likely associated with SBRT). All dose-limiting toxicities and late toxicities will be graded and tabled by lesion site stratum and SBRT fraction dose level. Toxicity attribution to either SBRT or ipilimumab will be described if possible.

  • Overall survival [ Time Frame: Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months ]
    Will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.


Other Outcome Measures:
  • Lymphocyte activation [ Time Frame: Up to 60 days after last ipilimumab injection ]
    Outcomes will first be described using plots and descriptive statistics. Natural log transformation may be applied, as necessary, prior to statistical comparison. Within-patient differences (e.g., baseline vs. post-treatment) will be examined by student's t test for paired data or nonparametric Wilcoxon signed rank test.

  • Lymphocyte analysis [ Time Frame: Up to 60 days after last ipilimumab injection ]
    Outcomes will first be described using plots and descriptive statistics.

  • T cell response [ Time Frame: Up to 60 days after last ipilimumab injection ]
    The number of immune responses (> 2 fold pre/post increase) will be tabled by fraction dose level. The overall immune response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients treated at the MTD.


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Primary Completion Date: March 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (stereotactic body radiotherapy, ipilimumab)
Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab IV every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Name: SBRT

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab.

SECONDARY OBJECTIVES:

I. To determine late toxicity and immune pharmacodynamic changes after SBRT followed by ipilimumab.

OUTLINE:

Patients undergo a total of 3 fractions of stereotactic body radiotherapy between days 1-13. Patients then receive ipilimumab intravenously (IV) every 3 weeks. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up within 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of melanoma
  • Previously treated or previously untreated stage IV melanoma by American Joint Committee on Cancer (AJCC) staging criteria
  • Presence of an index lesion between 1 and 5 cm
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Signed informed consent document
  • Adequate renal, hepatic, and hematologic indices for ipilimumab therapy
  • Ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment)

Exclusion Criteria:

  • Prior systemic therapy within 14 days of study enrollment; patients must be adequately recovered from prior systemic therapy side effects as deemed by the treating investigator
  • Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
  • Presence of central nervous system metastasis (including active brain metastasis); active brain metastasis would be defined as untreated brain metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active
  • Long-term use of systemic corticosteroids; patients with replacement steroids and not immunosuppressive steroids may enroll in the study
  • Prior radiation therapy (RT) that precludes the delivery of SBRT
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970527


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Ramesh Rengan    206-598-4110    Rengan@uw.edu   
Principal Investigator: Ramesh Rengan         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ramesh Rengan Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01970527     History of Changes
Other Study ID Numbers: 9031
NCI-2013-01757 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9031 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2013
First Posted: October 28, 2013
Last Update Posted: August 8, 2017
Last Verified: August 2017

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs