Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients the undergo metastasectomy. Beginning 4-8 weeks, patients with unresectable sarcoma may receive chemotherapy.

Metastatic Bone Sarcoma

Metastatic Malignant Neoplasm in the Lung

Metastatic Soft Tissue Sarcoma

Metastatic Unresectable Sarcoma

Resectable Sarcoma

Cisplatin

Isolated Chemotherapeutic Lung Perfusion

Metastasectomy

Roswell Park Cancer Institute

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Soft Tissue or Bone Sarcoma Metastatic to the Lungs

Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable Sarcoma Pulmonary Metastases

Dose limiting toxicities (DLTs) will be defined based on the rate of drug-related grade 3-5 adverse events. These will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

Will be treated as bivariate time-to-event data. Freedom from local recurrence will be summarized using standard Kaplan-Meier methods and the 2-year local recurrence-free rate will be estimated with a 90% confidence interval calculated using Greenwood's formula.

Will be summarized using standard Kaplan-Meier methods, where estimates of the median survival and 2-year survival rates will be obtained with 90% confidence intervals.

Assessed using the NCI CTCAE v5.0. Will be summarized by grade within each arm using frequencies and relative frequencies.

Will be compared between the suffused and non-suffused lungs using McNemar?s test. A 90% confidence interval about the difference in local recurrence rates will also be obtained.

The association between lung injury and response and survival outcomes will be evaluated using logistic and Cox regression models.

Will be correlated to primary endpoints. The cytokine activation, tumor, immune, and stress related biomarkers will be summarized using the appropriate descriptive statistics. The association between overall response and the biomarkers will be evaluated using logistic regression models. The association between time-to-event outcomes (freedom from recurrence and survival) and the biomarkers will be evaluated using Cox regression models. All model assumptions will be verified graphically and fit using Firth's method.

Will be compared to historical controls. Will be summarized using standard Kaplan-Meier methods, where estimates of the median survival and 2-year survival rates will be obtained with 90% confidence intervals.

National Cancer Institute (NCI)

- DNA and RNA from blood - Stool samples for microbiome analysis - Urine samples for microbiome and general biomarker analysis - Saliva samples for microbiome and general biomarker analysis - Blood for general biomarker and metabolite profiling

Li-Fraumeni Syndrome

Hereditary Cancer Syndromes

TP53 Gene Germline Mutation Carrier

Scripps Clinic Medical Group

Biomarker Monitoring in TP53 Mutation Carriers

Biomarker Monitoring for a Young Individual Carrying a TP53 Gene Mutation in a Familial High-Cancer Predisposition Setting

Laura Goetz

Staff Surgeon

Scripps Health

J. Craig Venter Institute

Sarcoma

Bone Tumor

Patients will undergo DCE-MRI prior to, and within 18-24 days of starting chemotherapy. These studies are designed to determine if the DCE-MRI data will provide an a priori or early prognostic marker of tumor response. The dynamic MRI is done on a standard clinical scanner using standard techniques described below.
MR imaging studies will be acquired on a 1.5T GE (Milwaukee,WI) Signa LX scanner.

DCE-MRI

Memorial Sloan Kettering Cancer Center

Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors

New York Presbyterian Hospital

University of Oregon

University College, London

Montefiore Hospital

300 mg of testosterone enanthate by intramuscular injection once weekly for 16 weeks

Placebo (sesame oil) by intramuscular injection once weekly for 16 weeks

HIV Associate Weight Loss

Testosterone enanthate

Placebo

Charles R. Drew University

Testosterone and Physical Function in HIV+ Men

Testosterone and Physical Function in HIV Associate Weight Loss

A modification of the Margaria stair climb was used to assess stair-climbing power. participants were instructed to ascend a 12-step staircase as rapidly as possible, with ascent time recorded over the middle four steps (0.66 m) of the climb.

Participants were instructed to walk a 160-m flat course as fast as possible without running. Photoelectric cells and timers were used to determine time to the nearest 0.01 s. The faster of two trials was used to calculate walking speed (m/s).

To simulate daily activities such as carrying groceries or suitcases, participants carried a load equal to 20% of their body weight while walking a distance of 20 m as fast as possible on a flat course.

alkaline phosphatase/sarcoma

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Soft Tissue or Bone Sarcoma Metastatic to the Lungs

Biomarker Monitoring in TP53 Mutation Carriers

Dynamic Contrast Enhanced MRI(DCE-MRI)of Bone Tumors

Testosterone and Physical Function in HIV+ Men

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