Dexrazoxane for Soft Tissue Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Soft Tissue Sarcoma+9 MoreDexrazoxane - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether giving dexrazoxane with standard of care doxorubicin affects the progression of the disease.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Hemangiosarcoma
  • Fibrosarcoma
  • Epithelioid Sarcoma
  • Liposarcoma
  • Synovial Sarcoma
  • Leiomyosarcoma
  • Malignant Peripheral Nerve Sheath Tumor
  • Myxofibrosarcoma
  • Undifferentiated Pleomorphic Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Day 1
Ability of 3D echocardiogram to serve as an early marker of cardiac dysfunction by measuring echocardiogram parameters of left ventricular ejection fraction by comparing to 2D echocardiogram modified Simpson's biplane method of LVEF
Ability of 3D echocardiogram to serve as an early marker of cardiac dysfunction by measuring echocardiogram parameters of ventricular strain by comparing to 2D echocardiogram modified Simpson's biplane method of LVEF
Up to 12 months
Cardiac-related mortality
Incidence of heart failure or cardiomyopathy
Up to 5 years
Progression-free survival (PFS) (Arm 1 only)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Dexrazoxane
100%Nausea
100%Blood creatinine increased
100%Headache
50%Constipation
50%Blood urea increased
50%Lymphocyte count decreased
50%Platelet count decreased
50%Hypersensitivity
50%Infusion site reaction
50%Anaemia
50%Malaise
50%Aspartate aminotransferase increased
50%Febrile neutropenia
50%White blood cell count decreased
50%Purpura
50%Blood cholesterol increased
50%Pleurisy
50%Neutrophil count decreased
50%Alopecia
50%Pneumonia
This histogram enumerates side effects from a completed undefined Phase 1 & 2 trial (NCT01596088) in the Dexrazoxane ARM group. Side effects include: Nausea with 100%, Blood creatinine increased with 100%, Headache with 100%, Constipation with 50%, Blood urea increased with 50%.

Trial Design

2 Treatment Groups

Arm 2: control (standard of care doxorubicin)
1 of 2
Arm 1: dexrazoxane & standard of care doxorubicin
1 of 2

Active Control

Experimental Treatment

73 Total Participants · 2 Treatment Groups

Primary Treatment: Dexrazoxane · No Placebo Group · Phase 2

Arm 1: dexrazoxane & standard of care doxorubicinExperimental Group · 2 Interventions: Dexrazoxane, Doxorubicin · Intervention Types: Drug, Drug
Arm 2: control (standard of care doxorubicin)
Drug
ActiveComparator Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,528 Total Patients Enrolled
Brian A Van Tine, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
273 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Myxofibrosarcoma is a rare tumor of the soft tissue.
You have angiosarcoma.\n