Suspended

Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors

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What is being tested

palifosfamide

Drug
Who is being recruted

Urogenital Diseases+13

+ Genital Diseases

+ Endocrine System Diseases

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorIndiana University
Last updated: July 2, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To determine the response rate (complete response [CR]+partial response [PR]) of single agent palifosfamide in patients with refractory germ cell tumors. SECONDARY OBJECTIVES: I. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors. OUTLINE: Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

NCT01808534
Principal SponsorIndiana University
Last updated: July 2, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalTesticular DiseasesUrogenital NeoplasmsMale Urogenital DiseasesTeratomaTesticular Neoplasms

Criteria

9 inclusion criteria required to participate
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use a highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug
Laboratory test results must be within ranges established in the protocol
Patients are eligible after first line platinum based chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor (PMNSGCT) or late relapse ( > 2 years) not amenable to surgical resection
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10 exclusion criteria prevent from participating
No active clinically serious infections as judged by the treating investigator ( > CTCAE grade 2) including known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or active hepatitis C
No history of psychiatric illness/social situations that would limit compliance with study requirements
No presence of, or history of any illness or injury to the urinary tract which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events
Patients must be at least 4 weeks post major surgery or significant traumatic injury at time of study registration
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Indiana University Cancer Center

Indianapolis, United StatesOpen Indiana University Cancer Center in Google Maps

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, United States

Virginia Mason Medical Center

Seattle, United States
Suspended3 Study Centers