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Melanoma

Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma (9031)
RADVAX: A Stratified Phase I/II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
Status Conditions Phase Study ID
Recruiting Recurrent Melanoma
Stage IV Melanoma
Phase I/II 9031
NCT01970527
Summary

This phase I/II trial studies the side effects and best dose of stereotactic body irradiation (SBRT) and to see how well it works when given together with ipilimumab in treating patients with stage IV melanoma. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving SBRT with ipilimumab may be effective in treating melanoma.


Investigator
Ramesh Rengan
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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 or 1
  • 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)
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
May 22, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.