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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Wolfram Samlowski
Study ID
NCT01565837
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 10mg/kg administered intravenously over 90-minute period every 3 weeks for a total of four doses as tolerated. Maintenance ipilimumab (10 mg/kg intravenously every 3 months) will be administered beginning Week 24, as long as there is clinical benefit in the opinion of the investigator using immune related response criteria, and there are no novel or unexpected Grade 3 or 4 toxicities.
  • Stereotactic Ablative Radiosurgery (SART) — RADIATION
    Definitive radiotherapy will be administered to up to 1-5 lesions using SART techniques after initial dose of ipilimumab. Radiotherapy will be timed before start of 3rd cycle of ipilimumab treatment to maximize synergy (week 6).

Study Details

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 Dates

Start date
Aug 31, 2012
Status verified
Jan 2016
Primary completion
Nov 30, 2016
Completion
Nov 30, 2017

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + SART
    Patients with oligometastatic but unresectable malignant melanoma will receive induction ipilimumab plus concurrent SART followed by maintenance ipilimumab.

Primary Outcome Measure

Safety and tolerability of concurrent ipilimumab and SART - Acute Toxicity [ Time Frame: Week 9 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Comprehensive Cancer Centers of NevadaLas VegasNevada89148
Khin Win
[email protected]
702-419-5550

Find similar trials in Las Vegas, NV

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Comprehensive Cancer Centers of Nevada· Las Vegas, NV

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