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Clinical Trial Detail

Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma

Complete title: RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy followed by Ipilimumab in Metastatic Melanoma

Research Study Number 9031
Principal Investigator Ramesh Rengan
Phase II

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older (Adult, Senior)

Sexes Eligible for Study: All

- 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)

Other eligibility criteria may apply.

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 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metastases; if the brain metastases have received prior treatment (usually either with surgery or radiation), they are no longer active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

Other exclusion criteria may apply.

Research Study Number 9031
Contact Marge Koe
Telephone 206/598-4127

Keywords: Melanoma; Skin Cancer; Solid Tumors; Neoplasms, Germ Cell and Embryonal; Neuroendocrine Tumor; Neoplasms; Neuroectodermal Tumors; Neoplasms, Nerve Tissue; Immunotherapy

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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.

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