Clinical trial NCT01970527: Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
Official title: RADVAX: A Stratified Phase II Dose Escalation Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Recurrent Melanoma
Stage IV Skin Melanoma
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-10-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. To determine feasibility and immune-related clinical responses associated with SBRT when given in conjunction with ipilimumab.

SECONDARY OBJECTIVES:

I. To determine 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 60 days, and then every effort will be made to obtain records of patients during this follow up, and permission will be sought for the investigators and/or study team to re-contact the patient directly with regard to health status and toxicity.

Eligibility 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 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

Primary outcomes:
measure: 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
timeFrame: Up to 60 days after last ipilimumab injection
measure: Immune-related Progression-free Survival (irPFS)
timeFrame: 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
measure: Late Toxicities, Graded According to the Radiation Therapy Oncology Group/European Organization for Research, the Treatment of Cancer Late Morbidity Scoring System, and the Common Terminology Criteria for Adverse Events Version 4.0
timeFrame: Up to 3 years
measure: Overall Survival
timeFrame: Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Ramesh Rengan
role: PRINCIPAL_INVESTIGATOR
References: