Preoperative 1 month use of teriparatide, before lumbar fusion surgery

Osteoporosis

Fusion of Spine, Lumbar Region

20ug dosage daily injection, 1-month preoperative

Teriparatide

Jason Pui Yin Cheung

Duchess of Kent Children's Hospital

Queen Mary Hospital

Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery

Effect of 1 Month Preoperative Teriparatide Use on the Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery

Measurement of the insertional torque of pedicle screws

Assessment of BMD before and after treatment

This is a self-perceived severity of back pain. The scores range from minimum 0 (no pain) to maximum 10 (most painful) in a scale of severity. Hence, a higher value represents worse outcome. There are two subquestions: 1) What the patient indicates as the most severe pain in the past 24 hours of answering the questionnaire; 2) The patient indicates the score of the usual pain status in the past 24 hours. 0 represents no pain, 1-3 represents mild pain (nagging, annoying, interfering little with ADLs), 4-6 represents moderate pain (interferes significantly with ADLs), and 7-10 represents severe pain (disabling; unable to perform ADLs).

This is a general osteoporosis score with 15 questions split into three categories (mobility, balance and transfer). A Likert scale of 6 answers are possible for each question from "no difficulties" to "unable to perform" in a scale of severity. A total score can be tabulated from adding all domain scores. Higher values indicate better outcome. A 0-100 scale provides a total score, where 0 indicates the worst health status and 100 no difficulties.

To assess patients' understanding of the disease and their views towards osteoporosis

The University of Hong Kong

To detect any significant difference between control and teriparatide groups in terms of intraoperative insertional torque strength

Patients receive niraparib orally daily and radium Ra 223 dichloride IV over 1 minute every 4 weeks. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Prostate Carcinoma Metastatic to the Bone

Stage IV Prostate Adenocarcinoma

Hormone-refractory Prostate Cancer

Niraparib

Radium Ra 223 Dichloride

University of Alabama

University of Chicago Medical Center

Tulane University

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

There will be three dose levels of niraparib combined with standard doses of Radium 223 to be evaluated for safety

Janssen, LP

Prostate Cancer Clinical Trials Consortium

Bayer

Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone

Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin

Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone

Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin

Cycles 1 and 2: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 12-hour infusion and cisplatin is administered alone
Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)
High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

Arm 1

Cycles 1 and 2: HDMTX administered as a 4-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin
Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)
High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

Arm 2

Cycles 1 and 2: HDMTX administered as a 12-hour infusion and pantoprazole is administered with cisplatin Cycles 3 and 4: HDMTX administered as a 4-hour infusion and cisplatin is administered alone
Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)
High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

Arm 3

Cycles 1 and 2: HDMTX administered as a 12-hour infusion and cisplatin is administered alone Cycles 3 and 4: HDMTX administered as a 4-hour infusion and pantoprazole is administered with cisplatin
Pantoprazole: 0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)
High-dose methotrexate infusion duration: High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

Arm 4

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Region of Enrollment

This measure describes the urinary biomarkers of AKI after each course of C throughout Cycles 1-2, compared to baseline (pre-infusion) values.
Biomarkers of AKI, include: Kidney Injury Molecule-1 (KIM-1), and Neutrophil Gelatinase-Associated Lipocalin (NGAL).

Arm 1 receives a 4-hour infusion of HDTX, and Arm 3 receives a 12-hour infusion of HDTMX, during Cycles 1 & 2. Both arms also receive C and PTZ during Cycles 1 & 2.

Treatments Arms 1 & 3 (Groups With PTZ in Cycles 1 & 2)

Am 2 receives a 4-hour infusion of HDTMX, and Arm 4 receives a 12-hour infusion of HDTMX during Cycles 1 & 2. Both arms also receive the C doses, but without PTZ.

Treatments Arms 2 & 4 (Groups Without PTZ in Cycles 1 & 2)

Change in Urinary Biomarkers of Acute Kidney Injury (AKI) Between Pre-Treatment (Baseline), After CISplatin (C) Treatments, and After HDTMX Treatments

Response of the primary tumor to the first two treatment cycles (Cycles 1 and 2) will be assessed by quantifying the change in tumor volume on MRI, after treatment (pre-operative) relative to the pre-treatment tumor volume. By using the log ratio of the tumor volume post-treatment, to the tumor volume pre-treatment. The larger the change, the more effective the treatment.

Localized Disease at Baseline

Metastatic Disease at Baseline

Change in Tumor Volume

Urinary biomarkers of acute kidney injury (AKI) and glomerular filtration rate (GFR) estimated from serum cystatin C will be compared to standard measures of renal function (serum creatinine, urinalysis, estimated creatinine clearance, fractional excretion of Mg). Single reported values are averaged and reported with full ranges.

Treatment Arms 1, 3 (w/ Pantoprazole)

Treatment Arms 2, 4 (w/o Pantoprazole)

Validating Urinary Biomarkers

Tissue microarray will be constructed from biopsy specimens, primary resection and resected metastatic tumors to evaluate the expression of proteins that are responsible for resistance to the drugs in the MAP regimen and to assess expression of proteins that are targeted by new anticancer drugs under development for childhood cancers.

Tissue Microarray

Serum BSAP will be longitudinally evaluated as a potential biomarker for osteosarcoma

Bone Specific Alkaline Phosphatase (BSAP)

Nutritional status (weight, arm circumference, skin fold thickness, pre-albumin) will be throughout the course of treatment

Individual Subjects

Nutritional Status

PROS survey measures quality of life for pediatric oncology patients, in 17 scaled questions. Each question scaled 0-4 (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Almost Always). The higher the final sum of the questions, the lower the quality of life/more severe the side effects of oncology treatment. Total scores can range between 0 = highest quality of life, and 100 = experiencing most severe side effects of oncology treatment/worst quality of life experience.

All participants in the study, regardless of which arm or order they were randomized to receive the study treatment.

All Study Participants (Arms 1-4)

Patient Reported Outcome Survey (PROS)

Average hearing level (HL) threshold in decibels (dB) over the frequency range of 4,000-8,000 hertz (Hz) will be derived separately for each ear from audiograms performed before each dose of cisplatin.

Ototoxicity

Cycles 1 & 2: HDMTX 4h, PTZ+C; Then Cycles 3 & 4: HDTMX 12h, C

Cycles 1 & 2: HDMTX 4h, C; Then Cycles 3 & 4: HDTMX 12h, C+PTZ

Cycles 1 & 2: HDMTX 12h, PTZ+C; Then Cycles 3 & 4: HDTMX 4h, C

Cycles 1 & 2: HDMTX 12h, C; Then Cycles 3 & 4: HDTMX 4h, C+PTZ

Overall Study

Frank Balis, MD

Osteosarcoma

Nephrotoxicity

0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)

Pantoprazole

High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours

High-dose methotrexate infusion duration

Children's Hospital of Philadelphia

Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy

Pilot Study to Prevent Nephrotoxicity of High-Dose Methotrexate by Prolonging the Infusion Duration and Prevent Nephrotoxicity and Ototoxicity of Cisplatin With Pantoprazole in Children, Adolescents and Young Adults With Osteosarcoma

Gateway for Cancer Research

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.

bone neoplasms/phosphatase

Preoperative Teriparatide Use on Insertional Torque of Pedicle Screws for Lumbar Fusion Surgery

Phase IB Trial of Radium-223 and Niraparib in Patients With Castrate Resistant Prostate Cancer (NiraRad)

Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy

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

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