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Chemotherapy

Chemotherapy for Lung Cancer

Phase 1
Recruiting
Led By Marcelo Cypel, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age less than 65 years
3 or more lung lesions in total
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for people under 65 with sarcoma that has spread to both lungs, where one lung can be treated with surgery or radiation. They must have at least three lung lesions and no cancer outside the lungs. Patients should be relatively fit (ECOG 0-2) and not have had a lot of doxorubicin before.Check my eligibility
What is being tested?
The study tests In Vivo Lung Perfusion (IVLP), a technique delivering chemotherapy directly into the lungs during surgery, aiming to kill unseen cancer cells while reducing harm to other organs. One lung gets IVLP; the other is treated normally as a control.See study design
What are the potential side effects?
While IVLP aims to reduce side effects by targeting only the lungs, potential risks may include typical chemotherapy side effects like heart damage, immune system suppression, nausea, hair loss, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am under 65 years old.
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I have three or more spots on my lungs.
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I can take care of myself and am up and about more than half of the day.
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My cancer has spread to both lungs.
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My cancer on the opposite side can be treated with surgery or radiation.
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I have been diagnosed with soft tissue or bone cancer.
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My cancer has not spread beyond my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Maximal tolerated dose by using a titration design
Safety of IVLP at selected dose levels by acute lung injury findings

Side effects data

From 2016 Phase 3 trial • 854 Patients • NCT00003389
98%
Anemia
93%
Leukocytes decreased
90%
Lymphopenia
84%
Neutrophils decreased
78%
Neuropathy-sensory
75%
Alopecia
74%
Fatigue
67%
Nausea
60%
Hyperglycemia
52%
Constipation
46%
Hypoalbuminemia
40%
Myalgia
34%
Stomatitis
33%
Insomnia
32%
Vomiting
27%
Platelets decreased
26%
Alkaline phosphatase increased
26%
Aspartate aminotransferase increased
23%
Dyspnea
20%
Dyspepsia
19%
Dysphagia
19%
Headache
16%
Anorexia
16%
Arthralgia
15%
Neuropathy-motor
15%
Abdominal pain
14%
Infection w/o neutropenia
14%
Cough
14%
Fever
13%
Rash/desquamation
13%
Diarrhea w/o prior colostomy
12%
Bone pain
11%
Weight gain
11%
Taste disturbance
11%
Anxiety/agitation
10%
Sweating
10%
Radiation dermatitis
9%
Rigors/chills
9%
Dizziness/lightheadedness
9%
Injection site reaction
8%
Hypoglycemia
8%
Dysphagia-esophageal radiation
8%
Blood bilirubin increased
8%
Chest pain
8%
Pain-other
8%
Phlebitis
7%
Creatinine increased
7%
Edema
7%
Pruritus
6%
Hot flashes
6%
Infection w/ grade 3 or 4 neutropenia
6%
Weight loss
5%
Muscle weakness
5%
Depression
5%
Mouth dryness
4%
Transfusion: pRBCs
4%
Pneumonitis/pulmonary infiltrates
3%
Thrombosis/embolism
3%
Febrile neutropenia
3%
Irregular menses
3%
Nail changes
2%
Allergic rhinitis
1%
Allergic reaction
1%
Infection w/ unknown ANC
1%
Syncope
1%
Sinus tachycardia
1%
Dehydration
1%
Neuropathic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Stanford V)
Arm A (ABVD)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Doxorubicin 9 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 9mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Group II: Doxorubicin 7 mcg/ml - expansionExperimental Treatment1 Intervention
Expansion group at ideal dose
Group III: Doxorubicin 7 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 7mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Group IV: Doxorubicin 5 mcg/mlExperimental Treatment1 Intervention
Doxorubicin 5mcg/ml by in vivo lung perfusion during surgical resection of pulmonary metastases
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,505 Total Patients Enrolled
Marcelo Cypel, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Doxorubicin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02811523 — Phase 1
Soft Tissue Sarcoma Research Study Groups: Doxorubicin 5 mcg/ml, Doxorubicin 7 mcg/ml, Doxorubicin 9 mcg/ml, Doxorubicin 7 mcg/ml - expansion
Soft Tissue Sarcoma Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT02811523 — Phase 1
Doxorubicin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02811523 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Feb 2025