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Anti-tumor antibiotic

Dexrazoxane for Soft Tissue Sarcoma

Phase 2
Waitlist Available
Led By Brian A Van Tine, M.D., Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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
  • Pleomorphic Sarcoma
  • Leiomyosarcoma
  • Myxofibrosarcoma
  • Peripheral Nerve Sheath Tumor
  • Epithelioid Sarcoma
  • Liposarcoma
  • Synovial Sarcoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS) (Arm 1 Only)
Secondary outcome measures
Ability of 3D Echocardiogram to Serve as an Early Marker of Cardiac Dysfunction Compared to 2D Echocardiogram Modified Simpson's Biplane Method of LVEF
Cardiac-related Mortality
Early Detection of Cardiac Dysfunction by 2D Echocardiography Ventricular Strain Compared to 2D Echocardiography Ejection Fraction
+1 more

Side effects data

From 2022 Phase 2 trial • 73 Patients • NCT02584309
94%
Anemia
79%
Fatigue
77%
Lymphocytes decreased
69%
Neutrophil count decreased
53%
Hypoalbuminemia
50%
Constipation
47%
White blood cell decreased
44%
Edema limbs
42%
Hypocalcemia
39%
Nausea
39%
Hyponatremia
35%
Platelet count decreased
35%
INR increased
34%
Alopecia
32%
Mucositis oral
31%
Hypokalemia
31%
Febrile neutropenia
29%
Fever
29%
Headache
27%
Diarrhea
26%
Alkaline phosphatase increased
24%
Vomiting
24%
Anorexia
23%
Hyperglycemia
23%
Hematuria
23%
Thromboembolic event
21%
Aspartate aminotransferase increased
21%
Cough
21%
Activated partial thromboplastin time prolonged
19%
Alanine aminotransferase increased
19%
Dyspnea
18%
Arthralgia
18%
Hypernatremia
16%
Urinary tract infection
16%
Abdominal pain
15%
Productive cough
15%
Proteinuria
15%
Hypoglycemia
13%
Bone pain
13%
Infusion-related reaction
13%
Hypertension
11%
Muscle pain
11%
Anxiety
11%
Back pain
11%
Ejection fraction decreased
10%
Peripheral sensory neuropathy
10%
Chills
10%
Creatinine increased
10%
Tumor pain
10%
Myalgia
10%
Dysgeusia
10%
Insomnia
8%
Nasal congestion
8%
Post nasal drip
8%
Hiccups
8%
Rash maculo-papular
8%
Upper respiratory infection
8%
Lung infection
8%
Pain in extremity
8%
Hypotension
6%
Blood bilirubin increased
6%
Nail ridging
6%
Flu like symptoms
6%
Hyperkalemia
6%
Nail discoloration
6%
Cholesterol high
6%
Gastroesophageal reflux disease
6%
Blurred vision
6%
Gastric hemorrhage
6%
Hypomagnesemia
6%
Sepsis
6%
Spinal fracture
6%
Dizziness
6%
Spasticity
6%
Malaise
5%
Sinusitis
5%
Sore throat
5%
Lymphedema
5%
Epistaxis
5%
Dysphasia
5%
Rash acneiform
5%
Watering eyes
5%
Confusion
5%
Dyspepsia
5%
Non-cardiac chest pain
5%
Oral pain
5%
Fracture
5%
Syncope
5%
Papulopastular rash
3%
GGT increased
3%
Hypercalcemia
3%
Flank pain
3%
Pneumonitis
3%
Hemorrhoids
3%
Nail infection
3%
Dysphagia
3%
Dehydration
3%
Dry skin
3%
Hypertriglyceridemia
3%
Knee pain
3%
Phantom pain
3%
Depression
3%
Hypothyroidism
3%
Ascites
3%
Abdominal distension
3%
Lower gastrointestinal hemorrhage
3%
Colitis
3%
Failure to thrive
3%
Edema trunk
3%
Skin infection
3%
Muscle spasms
3%
Dysarthria
3%
Urticaria
3%
Hand and foot syndrome
3%
Urinary frequency
3%
Photosensitivity
3%
Nail loss
3%
Hoarseness
3%
Dry mouth
2%
Hyperparathyroidism
2%
Tooth infection
2%
Thigh pain
2%
Restlessness
2%
Palmar plantar erythrodysesthesia syndrome
2%
Skin hyperpigmentation
2%
Mucosal infection
2%
Bloating
2%
Ear pain
2%
Ear sensitivity
2%
Anal hemorrhage
2%
Flatulence
2%
Wound infection
2%
Allergic rhinitis
2%
Subcutaneous tissue disorder
2%
Pelvic pain
2%
Shoulder pain
2%
Muscle aches
2%
Upper gastrointestinal hemorrhage
2%
Neuroma
2%
Tremor
2%
Rash non pruritic
2%
Capillary leak syndrome
2%
Akathisia
2%
Hyperthyroidism
2%
Glaucoma
2%
Sinus tachycardia
2%
Respiratory failure
2%
Leukocytosis
2%
Myositis
2%
Sinus bradycardia
2%
Gum bleeding
2%
Pain
2%
Eye infection
2%
Hallucinations
2%
Wheezing
2%
Intercardial thrombic
2%
Suicide
2%
Irritability
2%
Vaginal infection
2%
Rectal bleeding
2%
Esophagitis
2%
Lip swelling
2%
Thrombocytopenia
2%
Myocardial infarction
2%
Sudden death NOS
2%
Bleeding hemorrhoids
2%
Lymph node pain
2%
Chest pain - cardiac
2%
Tinnitus
2%
Vertigo
2%
Localized edema
2%
Allergic reaction
2%
Rectal ulcer
2%
Small intestinal obstruction
2%
Stomach pain
2%
Bruising
2%
Bacteremia
2%
Rash pustular
2%
Rhinitis infection
2%
Extrapyramidal disorder
2%
Sinus pain
2%
Hypermagnesemia
2%
Arthritis
2%
Chest wall pain
2%
Elevated PSA
2%
Mental status altered
2%
Psychosis
2%
Vaginal discharge
2%
Nodule left forearm
2%
Penile pain
2%
Pneumonia
2%
Sweating
2%
Tick bites
2%
Superficial thrombophlebitis
2%
Palpitations
2%
Hot flashes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: Doxorubicin and Upfront Dexrazoxane
Arm 2: Control (Doxorubicin and Standard of Care Dexrazoxane)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Doxorubicin and Upfront DexrazoxaneExperimental Treatment2 Interventions
Dexrazoxane will be given intravenously on an outpatient basis over 15 minutes on each day that doxorubicin is given. Dexrazoxane should be given no more than 30 minutes prior to administration of doxorubicin, which is typically given on Day 1 of a 21-day cycle. Dosing is a 10:1 ratio of dexrazoxane to doxorubicin; doxorubicin is typically given at 75 mg/m2, so dexrazoxane dosing would be 750 mg/m2. In the event of a national shortage of dexrazoxane, 72-hour infusional doxorubicin can be used instead of dexrazoxane and bolus doxorubicin..
Group II: Arm 2: control (Doxorubicin and Standard of Care Dexrazoxane)Active Control2 Interventions
Doxorubicin is given as standard of care. Doxorubicin is typically given at 75 mg/m2 on Day 1 of a 21-day cycle. Starting with cycle 5, standard of care dexrazoxane (75 mg/m2) will be given for 4 cycles. The last 10 patients enrolled after completion of enrollment to Arm 1 will be enrolled to Arm 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexrazoxane
2016
Completed Phase 2
~80
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,015 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are part of this experiment?

"As of now, this clinical trial does not have any open positions. However, this may change in the future as the study was last updated on 4/19/2022. There are currently 521 other trials for fibrosarcoma and 386 studies involving Dexrazoxane that are actively recruiting patients if you are interested."

Answered by AI

Could you please share any other scientific research that has been conducted with Dexrazoxane?

"As of now, there are 386 ongoing studies observing the effects of Dexrazoxane. Out of these, 121 are in Phase 3. Additionally, while a few investigations are taking place in Providence, Rhode island, there are 23157 other sites running similar trials."

Answered by AI

Has this type of clinical trial been conducted before?

"As of now, there are 386 ongoing clinical trials for Dexrazoxane in 67 different countries and 1935 cities. The very first trial happened in 1997 and was sponsored by Alfacell. That study had 300 participants and completed Phase 3 drug approval. In the 24 years since then, 680 more trials have taken place."

Answered by AI

Has Dexrazoxane received approval from the Federal Drug Administration?

"Dexrazoxane is a Phase 2 drug, so while there is some safety data, we do not yet know if it is effective. Our team rates its safety as a 2."

Answered by AI

If a patient wanted to enroll today, would they be able to?

"As of right now, this clinical trial is not looking for any more patients. It was first posted on February 22nd, 2016 and last updated on April 19th, 2022. If you are interested in other research opportunities, 521 trials for fibrosarcoma and 386 studies involving Dexrazoxane are currently admitting patients."

Answered by AI

What are some common conditions that Dexrazoxane is used to manage?

"Dexrazoxane is an effective treatment for patients suffering from malignant lymphomas, kaposi's sarcoma aids related, and neoplasm metastasis."

Answered by AI
~8 spots leftby Mar 2025