IRB Study Number 22-901
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary Objective
2.1.1 To evaluate the impact of SBRT on the immune system by measuring the neutrophil to lymphocyte ratio for patients with metastatic or unresectable sarcoma.
2.2 Secondary Objective(s)
2.2.1 To evaluate local control with SBRT for metastatic or unresectable sarcoma using the biologically effective dose (BED) of > 95 Gy of SBRT identified from our previously treated patient population.
2.2.2 To estimate rates of acute ≥ grade 3 CTCAE, v. 5.0 adverse events related to SBRT using the biologically effective dose (BED) of > 95 Gy of SBRT.
2.2.3 To evaluate the impact of SBRT on the immune system by collecting laboratory data for patients with metastatic or unresectable sarcoma including Immune and inflammatory markers via Olink, Myeloid-derived suppressor cells (MDSC), complete blood count (CBC) with differential, Albumin, Lactate Dehydrogenase (LDH), and C-reactive protein (CRP)
2.3 Exploratory Objectives (s)
2.3.1 To evaluate the impact of SBRT on the quality of life for our patients utilizing the peds QOL age-specific instruments for patients up to age 25 and for all others using the standard questionnaires available through EPIC
2.3.1 To correlate immune and inflammatory markers with local controls and overall survival outcomes in patients with metastatic or unresectable sarcoma.
Inclusion Criteria
3.1.1 Subjects must have histologically or cytologically (by biopsy or tissue) confirmed diagnosis of sarcoma (for example but not limited to ESFT, Osteosarcoma, RMS, NRSTS).
3.1.2 Subjects must have at least one lesion appropriate for SBRT as determined by the treating radiation oncologist. This can either be a metastatic site or a locally recurrent site in the setting of prior treatment. The site can be anywhere in the body including, but not limited to bone, soft tissue, lung, and brain.
3.1.3 Age ≥ 12 years. The impact of SBRT on children <12 years of age is not well known and beyond the scope of this study.
3.1.4 Performance status: Karnofsky Performance status ≥ 60% or Lansky Play Scale ≥ 60%
3.1.5 Life expectancy of ≥ 3 months, in the opinion of the investigator.
3.1.6 Patients must have a documented metastatic workup as clinically indicated within 45 days prior to study registration as determined by the treating physician specific to the diagnosis/tumor location. For example: CT or MRI scans of the chest OR when appropriate radionuclide bone scan OR whole body PET/CT.
3.1.7 Subjects must have adequate organ and marrow function within 30 days prior to registration on study as defined below:
o Absolute neutrophil count (ANC) ≥ 500 cells/mm3;
o Platelets ≥ 50,000 /mm3;
o Hemoglobin ≥ 7.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 7.0 g/dl is acceptable.)
o If liver metastases present, AST and ALT must be < 3X ULN
3.1.8 For data collection, must be evaluated by a medical/pediatric oncologist within 45 days prior to study registration. On-line consults or virtual visits are acceptable.
3.1.9 Patients of age (18 years or older) or legal guardian (if patients younger than 18) must provide study specific informed consent prior to study entry.
3.1.10 For females of child-bearing potential getting SBRT, negative serum/urine pregnancy test must be documented within 14 days prior to study registration.
3.1.11 Patients getting SBRT must be able to safely receive at least an equivalent of SBRT delivered in 35 Gy over 5 fractions or higher (equivalent to a biologically effective dose (BED) of > 95 Gy
3.1.12 Patients must be screened for corticosteroid use. If they are receiving corticosteroids there must be a discussion with the primary investigator to determine whether the treatment is necessary and whether the patient can be tapered off prior to delivery of SBRT. The ideal goal would be to have the patient tapered off prior to initiating SBRT.
Exclusion Criteria
3.2.1 Prior treatment toxicities that impact vital organ function related to radiotherapy/ SBRT not resolved to ≤ Grade 2 according to NCI CTCAE Version 5.0
3.2.2 Subjects receiving any concurrent immunotherapy (unless discussed and approved by the primary investigator).
3.2.3 Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with SBRT study requirements.
3.2.4 Pregnant or breastfeeding women are excluded from the SBRT because SBRT has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with SBRT, breastfeeding should be discontinued if the mother is treated with SBRT.
3.2.5 Subjects who are HIV-positive or have other underlying immune deficiencies will be excluded from the study as this is an evaluation of the effect of SBRT on the immune system, the immunosuppressed nature of these patients may compromise the data.
