Doxorubicin for Soft Tissue Sarcoma

Princess Margaret Cancer Centre, Toronto, Canada
Soft Tissue Sarcoma+2 More ConditionsDoxorubicin - Drug
Eligibility
No minimum age - 64
All Sexes

Study Summary

This trial is testing a new technique for delivering chemotherapy directly into the lungs at the time of surgery. The goal is to kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Bone Sarcoma
  • Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Maximal tolerated dose by using a titration design
Safety of IVLP at selected dose levels by acute lung injury findings

Trial Safety

Phase-Based Safety

1 of 3

Side Effects for

Arm A (ABVD)
91%Leukocytes decreased
90%Anemia
82%Neutrophils decreased
77%Fatigue
77%Lymphopenia
76%Nausea
69%Alopecia
47%Neuropathy-sensory
47%Constipation
46%Hyperglycemia
46%Vomiting
45%Hypoalbuminemia
38%Alkaline phosphatase increased
33%Stomatitis
32%Myalgia
29%Platelets decreased
28%Aspartate aminotransferase increased
28%Cough
27%Dyspnea
20%Infection w/o neutropenia
20%Anorexia
19%Bone pain
18%Diarrhea w/o prior colostomy
17%Headache
16%Dyspepsia
16%Insomnia
15%Fever
13%Taste disturbance
13%Injection site reaction
12%Dysphagia
12%Abdominal pain
12%Hypoglycemia
11%Rash/desquamation
11%Arthralgia
10%Sweating
8%Dizziness/lightheadedness
8%Pain-other
8%Chest pain
8%Weight gain
8%Neuropathy-motor
8%Depression
8%Anxiety/agitation
7%Nail changes
7%Edema
7%Rigors/chills
7%Hot flashes
7%Pneumonitis/pulmonary infiltrates
6%Allergic rhinitis
6%Phlebitis
6%Pruritus
6%Blood bilirubin increased
6%Infection w/ grade 3 or 4 neutropenia
6%Creatinine increased
5%Weight loss
4%Radiation dermatitis
4%Dysphagia-esophageal radiation
3%Thrombosis/embolism
2%Mouth dryness
2%Febrile neutropenia
2%Muscle weakness
1%Dehydration
1%Hypoxia
1%Syncope
1%(DLCO) decreased
1%Neuropathic pain
1%Transfusion: pRBCs
1%Cardiac-ischemia
1%Hypothyroidism
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT00003389) in the Arm A (ABVD) ARM group. Side effects include: Leukocytes decreased with 91%, Anemia with 90%, Neutrophils decreased with 82%, Fatigue with 77%, Lymphopenia with 77%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

9 Treatment Groups

Doxorubicin 7 mcg/ml - expansion
1 of 9
Doxorubicin 13 mcg/ml
1 of 9
Doxorubicin 11 mcg/ml
1 of 9
Doxorubicin 17 mcg/ml
1 of 9
Doxorubicin 20 mcg/ml
1 of 9
Doxorubicin 9 mcg/ml
1 of 9
Doxorubicin 5 mcg/ml
1 of 9
Doxorubicin 7 mcg/ml
1 of 9
Doxorubicin 15 mcg/ml
1 of 9

Experimental Treatment

17 Total Participants · 9 Treatment Groups

Primary Treatment: Doxorubicin · No Placebo Group · Phase 1

Doxorubicin 7 mcg/ml - expansion
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 13 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 11 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 17 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 20 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 9 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 5 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 7 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Doxorubicin 15 mcg/ml
Drug
Experimental Group · 1 Intervention: Doxorubicin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,396 Previous Clinical Trials
474,346 Total Patients Enrolled
Marcelo Cypel, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
21 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 64 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a medical condition on the other side of your body that can be treated with surgery or radiation.
The tumors in the lung that will be treated with IVLP can be removed with a small, minimally invasive surgery. If there are other tumors in the lung that will not be treated with IVLP, they will be treated with radiation or surgery before the IVLP treatment.

Frequently Asked Questions

Has the Food and Drug Administration sanctioned Doxorubicin for therapeutic use?

"Due to a lack of data regarding safety and efficacy, our team at Power assigned Doxorubicin an initial score of 1." - Anonymous Online Contributor

Unverified Answer

Does the age criteria for this clinical experiment encompass those who are octogenarians or older?

"This medical trial is restricted to those ages 0-64. Conversely, 309 trials are currently available for minors and 2680 exist for seniors over the age of 65." - Anonymous Online Contributor

Unverified Answer

Is registration still available for this investigation?

"Clinicaltrials.gov reveals that this medical trial is not accepting new participants at the moment. The study was initially listed on February 1st 2016 and its page last modified on April 8th 2022. Although this test is closed to enrollment, there are 2863 other studies looking for volunteers presently." - Anonymous Online Contributor

Unverified Answer

Are there any documented precedents of experiments that use Doxorubicin?

"Currently, 360 clinical trials are being conducted to test the efficacy of Doxorubicin. Of these, 119 are in their final phase and primarily based in New York City; however, there are over 23000 sites gathering data from around the country." - Anonymous Online Contributor

Unverified Answer

To what demographic is this research project accessible?

"This specific clinical trial is recruiting 11 patients, aged 0 to 64 years old with sarcoma of the bone. As per inclusion criteria, they must have an ECOG score between 0 and 2, 3 or more lesions in their lungs accessible for treatment using IVLP (the remaining ones should be treated by surgery/radiation 4-12 weeks before commencing IVLP), be under 65 years old and present contralateral disease amenable to either radiation therapy or surgical resection." - Anonymous Online Contributor

Unverified Answer

To what extent is the capacity of this experiment being tested?

"At this time, this trial is not enrolling any additional participants. The study was posted on the 1st of February 2016 and last updated on April 8th 2022. If you are looking for other medical trials, there are presently 2503 studies with sarcoma-related research pursues that require volunteers as well as 360 clinical investigations concerning Doxorubicin which are actively recruiting patients." - Anonymous Online Contributor

Unverified Answer

What ailments is Doxorubicin primarily employed to address?

"Doxorubicin is commonly used as a form of therapy for lymphoma and Hodgkin's Disease. Additionally, it can be employed to treat conditions such as bronchogenic carcinoma, neuroblastoma (NB), and Sezary Syndrome." - Anonymous Online Contributor

Unverified Answer

Has a similar clinical trial been conducted in the past?

"Since its first trial in 1997, sponsored by Alfacell and involving 300 patients, doxorubicin has been studied extensively. Subsequently granted Phase 3 approval for use as a drug, 360 different trials are currently active across 1941 cities and 66 countries worldwide." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.