Compassionate Use of Aldoxorubicin in Sarcoma Patients Chemotherapy

October 21, 2015 updated by: CytRx

Compassionate Use of Aldoxorubicin in Sarcoma Patients Who Have Failed Prior Chemotherapy

Compassionate use of aldoxorubicin in sarcoma patients who have failed prior chemotherapy.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This is a compassionate use protocol allowing sarcoma patients that have relapsed after prior therapies and are not eligible for other protocols involving the evaluation of aldoxorubicin to receive aldoxorubicin.

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metastatic or unrectable sarcoma that has either relapsed or was refractory to at leat 1 prior chemotherapy or immunotherapy regimen and for which no standard approved therapy exists
  • Must not be eligible for another CytRx-sponsored clinical trial
  • Able to provide complete medical records for review by the CytRx Medical Monitor
  • Able to receive treatment at a site that is participating or has participated in another CytRx-sponsored aldoxorubicin trial
  • Capable of providing informed consent and complying with trial procedures
  • ECOG performance status 0-2
  • Measurable or evaluable tumor lesions according to RECIST 1.1 criteria
  • Women must not be able to become pregnant (eg post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study
  • Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating

Exclusion Criteria:

  • Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to screening for non-target lesion
  • Exposure to any investigational agent within 30 days of screening
  • Central nervous system metastases that are symptomatic
  • Laboratory values: Screening serum creatinine >1.5×ULN, ALT >3×ULN, or >5×ULN if liver metastases are present, total bilirubin >3×ULN, ANC <1,500/mm3, platelet concentration <100,000/mm3, hematocrit level <25% for females or <27% for males, coagulation tests (PT, PTT, INR) >1.5×ULN
  • Anion gap > 16 meq/L or arterial or venous blood pH < 7.30.
  • Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines
  • Current serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V
  • Baseline QTc >470 msec and/or previous history of QT prolongation while taking other medications. Concomitant use of medications associated with a high incidence of QT prolongation is not allowed
  • History or signs of active coronary artery disease with or without angina pectoris.
  • Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial scintigram) or ultrasound determined absolute LVEF <45% of predicted
  • History of HIV infection
  • Active, clinically signifiant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals
  • Major surgery within 3 weeks prior to enrollment
  • Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results

Study Plan

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

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CytRx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 21, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aldox Compassionate Use

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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