Concurrent Ipilimumab and Stereotactic Ablative Radiation Therapy (SART) for Oligometastatic But Unresectable Melanoma

Status unconfirmed · Phase 2

Conditions studied: Melanoma

In brief

The purpose of this study is to evaluate if precisely-targeted radiation therapy, known as stereotactic ablative radiotherapy (SART), given during treatment with the drug ipilimumab (Yervoy) will improve survival for patients with melanoma that has spread to five or fewer sites (oligometastatic). Blood samples will be collected for research purposes. Planned studies include exploration of certain gene mutations and serum markers as predictors of response to ipilimumab treatment. Research lab studies will also evaluate if circulating tumor cells (CTC) can be accurately detected and isolated from the blood using novel laboratory techniques and if they are a prognostic/predictive marker for treatment response. Test results will not be given to participants or their physicians. In some cases, CTC may be grown for long-term cell lines for further research.

Key facts

Study ID

NCT01565837

Run by

Wolfram Samlowski

People needed

50

Starts

2012-08-01

Expected to finish

2017-11-01

Last updated by the study team

2016-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage III or IV melanoma (AJCC 6th edition) with 5 or less metastatic sites that are not amenable to curative surgical resection, but can be adequately delineated for SART
• All sites of metastatic disease acceptable except brain-only and eye metastases, provided SART can be safely delivered to the site.
• Up to 2 prior systemic treatments for metastatic disease.
• Mucosal or ocular melanoma is allowed.
• Radiotherapy consultation and insurance preapproval for SART prior to enrollment.
• CT or MRI within 28 days of enrollment showing no evidence of brain metastases. Brain metastases allowed if stable by scans for ≥ 28 days following treatment.
• CT, PET/CT or MRI scan of chest, abdomen, pelvis (and soft tissue as indicated); bone scan (as indicated); and photographs of skin lesions (if applicable) within 28 days of enrollment.
• Hematology, liver function and renal function lab tests within required parameters.
• Recovered from all prior surgery and/or adjuvant treatment.
• No active or chronic infection with HIV, Hepatitis B or Hepatitis C.
• ECOG Performance Status 0 or 1.
• Men and women ≥ 18 years old.
• Men/Women of childbearing potential must use adequate contraception.

You may not qualify if…

• Untreated or uncontrolled brain metastases.
• Prior treatment with CTLA-4 agent, PD-1 or PD-1 ligand mAb or inhibitor for metastatic disease or as adjuvant therapy (or participation in blinded study).
• History of melanoma-associated retinopathy.
• History of other active malignancy within last 2 years, except adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of cervix, unless disease-free for 2 years.
• Autoimmune disease (vitiligo is not a basis for exclusion).
• History of clinically active diverticulitis (diverticulosis is not exclusion criterion per se).
• Serious uncontrolled medical disorder or active infection that would impede treatment.
• Underlying medical or psychiatric condition that would cause administration of ipilimumab to be hazardous, or would obscure interpretation of AEs.
• Any non-oncology vaccine therapy up to 1 month before or after any dose of ipilimumab.
• Concomitant therapy with IL-2, interferon, other non-study immunotherapy, or cytotoxic chemotherapy; immune-suppressive agents within 30 days of registration; other investigational therapies; chronic use of systemic corticosteroids (however, a low stable dose steroid for mild brain edema or adrenal insufficiency is allowed; topical and inhaled standard dose corticosteroids are allowed).
• Dementia or significantly altered mental status that would prohibit understanding or rendering of informed consent and compliance with protocol requirements.
• Pregnant or breastfeeding women.
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious) illness.

Where it is running

• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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