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. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01970527
First received: October 22, 2013
Last updated: August 4, 2014
Last verified: August 2014
  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 stereotactic body radiotherapy with ipilimumab may kill more tumor cells.


Condition Intervention Phase
Recurrent Melanoma
Stage IV Melanoma
Radiation: stereotactic body radiotherapy
Biological: ipilimumab
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Late toxicities, graded according to the Radiation Therapy Oncology Group/European Organization for Research and the Treatment of Cancer late morbidity scoring system [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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.

  • 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 3 years ] [ Designated as safety issue: No ]
    Scored on a non-index lesion using immune-related response criteria according to Wolchok et. al. 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 ] [ Designated as safety issue: No ]
    irPFS will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.

  • 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 ] [ Designated as safety issue: No ]
    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 analysis [ Time Frame: Up to 30 days after last ipilimumab injection ] [ Designated as safety issue: No ]
    Outcomes will first be described using plots and descriptive statistics.

  • Lymphocyte activation [ Time Frame: Up to 30 days after last ipilimumab injection ] [ Designated as safety issue: No ]
    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.

  • T cell response [ Time Frame: Up to 30 days after last ipilimumab injection ] [ Designated as safety issue: No ]
    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: September 2016 (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.
Radiation: stereotactic body radiotherapy
Undergo stereotactic body radiotherapy
Biological: ipilimumab
Given IV
Other Names:
  • anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • MDX-010
  • MDX-CTLA-4
  • monoclonal antibody CTLA-4
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine feasibility and immune-related clinical responses associated with stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery) when given in conjunction with ipilimumab.

SECONDARY OBJECTIVES:

I. To gather additional data on acute and 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 30 days, within 60 days, and then every 3 months thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 or history of central nervous system metastasis (including brain)
  • Long-term use of systemic corticosteroids
  • Prior radiation therapy (RT) that precludes the delivery of SBRT
  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: NCT01970527

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Ramesh Rengan    206-598-4110      
Principal Investigator: Ramesh Rengan         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Ramesh Rengan Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01970527     History of Changes
Other Study ID Numbers: 9031, NCI-2013-01757, 9031, P30CA015704
Study First Received: October 22, 2013
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014