Neoplasms

All Conditions

Rare Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Germ Cells Tumors

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Etoposide

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Ifosfamide

Etoposide phosphate

Bleomycin

Isophosphamide mustard

Mesna

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Paclitaxel 120 mg/m2 IV over 120-180 min Days 1 and 2 (+/- 4 days)\* Mesna 120 mg/m2 IV (duration of infusion per institutional guidelines) approximately 30 minutes prior to initiation of ifosfamide Days 1-5 (+/- 4 days)\* Ifosfamide 1200 mg/m2 IV over approximately 60 to 120 min Days 1-5 or per institutional guidelines (mixed 1:1 with mesna) (+/- 4 days)\* Mesna\*\* 1200 mg/m2 IV over approximately 60-120 min or per institutional guidelines (mixed 1:1 with ifosfamide)(+/- 4 days)\* Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)\*

\*\*Additional mesna may be given at the discretion of the investigator

\*Paclitaxel or Ifosfamide or Mesna or Cisplatin or any combination of these agents can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.

Cisplatin 20 mg/m2 IV over approximately 30 min Days 1-5 (+/- 4 days)\* Etoposide 100 mg/m2 IV over approximately 1 hour Days 1-5 (+/- 4 days)\* Bleomycin 30 U flat dose IV push Days 2, 8 and 15 (all +/- 4 days)

\*Etoposide or Cisplatin or both can be held as needed for patient safety on a given day between days 1-5 but must be made up within 4 days to avoid a protocol violation.

Darren Feldman, MD

The purpose of this study is to learn about the safety and effectiveness of two different drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT). One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure every patient and therefore newer treatments are needed.

Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors

Randomized Phase II Trial of Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-Risk Germ Cell Tumors

Favorable best response is defined as complete response or partial response with negative tumor markers. Patients will be considered evaluable for the primary endpoint of favorable response within the first 6 months if they complete at least 3 cycles of study treatment (without switch to an alternative chemotherapy regimen) and achieve a confirmed partial response with negative markers or confirmed complete response (considered as favorable responses). Patients will also be considered evaluable for the primary endpoint if they develop disease progression during the treatment portion of the study regardless of how many cycles of chemotherapy they received or if they achieve an incomplete response after completion of study treatment (considered as not having a favorable response)."

Overall best response refers to the best response achieved by a patient to either TIP or BEP over the course of the entire study.

Progression-free survival (PFS) will be calculated from the date of treatment start until disease progression, death, or last followup, whichever comes first. The following are included as PFS events: incomplete response (IR), relapse or disease progression, and death.

Overall survival will be calculated from the date of treatment start until death, regardless of the cause.

Toxicity will be assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade of each toxicity will be recorded for each patient over the course of treatment (all cycles). Special emphasis will be placed on comparisons of the frequency of Grade 3/4 toxicities between the TIP and BEP arms.

University of Southern California

Mayo Clinic

University of Pittsburgh

University of North Carolina

University of Chicago

Stanford University

University of Texas Southwestern Medical Center

Memorial Sloan Kettering Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart

HDR brachytherapy of 19 Gy delivered in a single fraction

High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.

HDR 2 Fraction

High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction

HDR 1 Fraction

Gerard Morton, MD

A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.

A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer

To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.

To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)

To determine changes in serum prostate-specific antigen (PSA) in both arms

To determine PSA failure and disease free survival rates in both study arms

To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale

To explore association between dosimetric parameters and toxicity/EPIC domain change

Sunnybrook Health Sciences Centre

Dr. Gerard Morton

Symptoms and General Pathology

Adenocarcinoma

Neoplasm Metastasis

Neoplasms, Glandular and Epithelial

Neoplastic Processes

Hormones

Immunomodulating Agents

C11-Sodium Acetate

Fabio Almeida, MD

Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.

OBJECTIVES:

* Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy.
* Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.

C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma

Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT

PSA (prostate specific antigen) will be monitored per routine clinical follow-up

Phoenix Molecular Imaging

Medical Director and Principal Investigator

Mark L Perman, MD

Debra E Freeman, MD

Mike Rickman

Fred Dumas, MD

Roger Ove, MD, PhD

Monica Baker, ROCC

Lauren D Stegman, MD

Bonnie Harkins, RN, OCN, CCRP

Brent Kane, MD

Amanda Schwer, MD

Patrick Linson, MD

Paul Kim, MD

Cami Bremer

Jodi Harr

Anuj Peddada, M.D.

Toni Cody

Kelley C Simpson, MD

Gregg Dickerson, MD

Greg Dickerson, MD

Linda Winger

Sean P Collins, MD, PhD

Gail Suarez

James Schwade, MD

Debra Freeman, MD

S Sundararaman, MD

Srinath Sundararaman, MD

Mark Perman, MD

Beth Kost

Mark McLaughlin, MD

Anne Dunlap

Andy Su, MD

Linda Green, BS,RN

Arica Hirsch, MD

Anne Wray

Alan Beckman, MD

Lee McNeely, MD

Kerstin Leigland, BA, CCRC

Kelly Underhill, MD

Holly Frydenlund

Jeffery Stephenson, MD

Kevin Yiee, MD

Isis Amoy

Dan L Curtis, MD

James Gann

Jonathan Tay, MD

Stephanie Ullo

Adnan Danish, MD

Michelle Karedes

Rashid Haq, MD

Kathy Corbett

Mandy Hess

Edward Hughes, MD

Candida Barlow, MSN, CTN, RN

Frederick Willison, MD

Katherine Wood

Diane Heaton, MD

Matt Weaver, BC, CCRC

Wendy Wheaton

Michael S Payne, MD

Cindy Winker

Michael Good, RN,BSN,MAR

John Lamond, MD

Sheila C Baucum, RN, APN-AOCNS

James R Gray, MD

Melissa Cronn

Paiman Ghafoori, MD

Timothy D Nichols, MD

Gail Wade

Matthew Cavey, MD

Catalina Gutierrez

Cheryl Fullmer

L. Steven Carpenter, MD

Melissa Blough, PhD

Joaquin G Mira, MD

Jeanetta Patterson, RN, BA OCN

Jeffery Gilmore, MD

Stephanie VanBebber

Samir Kanani, MD

Karie-Lynn Kelly, MD

Mathew

Karie- Lynn Kelly, MD

Kara Makin-Bond

Michael Myers, MD

Beverly Smith, BSN, OCN

Sanjeev Sharma, MD

Mark L. Perman, MD

To address pertinent questions regarding the utilization of stereotactic Body Radiotherapy (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT. The registry is designed to track surrogate treatment endpoints including prostate specific antigen (PSA), international prostate symptom score (IPSS),sexual health in men (SHIM), and visual analogue scale (VAS) scores, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries, FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data, requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

To address pertinent questions regarding the utilization of radiosurgery (SBRT) to treat prostate cancer. The Florida Robotic Radiosurgery Association (FRRA) launched the first registry for prostate cancer patients treated with SBRT.

The registry is designed to track surrogate treatment endpoints including PSA, IPSS, SHIM, QOL, Karnofsky Performance Status, VAS scores, urine and bowel health, in addition to physical and survival data. Utilizing an independent vendor (Advertek, Inc.) experienced with the design and implementation of similar electronic registries.

FRRA developed a data collection tool that staff members with a basic medical background can use to register and upload pertinent patient data requiring no more than 20 to 30 minutes per patient. Participating patients will be monitored in follow-up for three years, with analysis and publication of the results semi-annually.

Multi-Institutional Registry for Prostate Cancer Radiosurgery

Multi-Institutional Registry for Prostate Cancer Radiosurgery. An IRB Approved Observational Trial

Measurement of surrogate outcomes including IPSS and SHIM scores

urinary and rectal complications as well as sexual health

RPCR, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors	NCT01873326	Germ Cell Tumor...	Paclitaxel Ifosfamide Cisplatin Mesna Bleomycin Etoposide	18 Years -	Memorial Sloan Kettering Cancer Center
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre
C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma	NCT01530269	Prostate Cancer Prostate Adenoc...	C11-Sodium Acet...	18 Years - 90 Years	Phoenix Molecular Imaging
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer	NCT01890096	Carcinoma of th...	HDR 2 Fraction HDR 1 Fraction	18 Years -	Sunnybrook Health Sciences Centre
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors	NCT01873326	Germ Cell Tumor...	Paclitaxel Ifosfamide Cisplatin Mesna Bleomycin Etoposide	18 Years -	Memorial Sloan Kettering Cancer Center
Multi-Institutional Registry for Prostate Cancer Radiosurgery	NCT01226004	Prostate Cancer... Prostate Cancer...		18 Years - 90 Years	RPCR, Inc.
Multi-Institutional Registry for Prostate Cancer Radiosurgery	NCT01226004	Prostate Cancer... Prostate Cancer...		18 Years - 90 Years	RPCR, Inc.

Spots Global Cancer Trial Database for intermediate

Every month we try and update this database with for intermediate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.