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Drug Delivery Device

Drug Delivery Microdevice for Sarcoma

Q: Is this clinical endeavor actively seeking participants?

This clinical study, which was initially posted in January of 2023 and last updated at the end October 2022 is not currently recruiting. However, there are 2145 other trials enlisting participants presently.

Q: To what extent has enrollment for this medical experiment been completed?

At the present time, this particular medical trial is not seeking new patients. It was initially posted on January 31st 2023 and last amended on October 31st 2022. However, those wishing to participate in other studies may be interested to know that 446 clinical trials involving <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a> are actively recruiting while 1699 research projects related to Therapeutic Conventional Surgery still require participants.

Q: Has its kind of research been conducted before?

Globally, there are 1699 active studies evaluating Therapeutic Conventional Surgery in 2965 cities across 75 countries. This research has its roots in a 1997 Phase 3 drug approval trial sponsored by Alfacell, which recruited 300 patients to participate. Since then, 3439 additional trials have been completed.

Q: Can you tell me about any research conducted to date concerning Therapeutic Conventional Surgery?

At present, there are 1699 clinical trials related to Therapeutic Conventional Surgery in progress. Of these studies 333 are at the phase 3 level and most of them can be found within Bethesda, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>; however, 56616 locations across the globe possess active Therapeutic Conventional Surgery investigations.

Q: In what medical conditions is Therapeutic Conventional Surgery an effective treatment?

Therapeutic Conventional Surgery can be employed to treat joints, refractory <a href="https://www.withpower.com/clinical-trials/ewing-sarcoma">ewing sarcoma</a> and kaposi's sarcoma-related <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a>.

Phase < 1

Waitlist Available

Led By Joseph A Ludwig

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a biopsy-confirmed recurrent or metastatic sarcoma for which surgery is indicated as a standard of care

Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial is testing the side effects of a microdevice that is implanted with drugs in order to treat sarcomas.

Who is the study for?

This trial is for people aged 10 or older with sarcoma that has spread or returned, and who need surgery as part of their treatment. They must be able to perform daily activities (ECOG <=2) and consent to participate. It's not for those under 10, pregnant or breastfeeding women, patients refusing surgery, or with allergies to drugs in the microdevice.Check my eligibility

What is being tested?

The study tests a tiny implantable device containing microdoses of various drugs like Doxorubicin and Everolimus directly into sarcoma tumors. The goal is to see which drugs affect tumor tissue when delivered through this new method during standard surgical care.See study design

What are the potential side effects?

Potential side effects include reactions at the implant site, possible allergic responses to any of the contained drugs such as skin rashes or breathing difficulties, and general risks associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My sarcoma has returned or spread and surgery is recommended.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am at least 10 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.

To assess efficacy across all individual agents or drug combinations tested using the microdevice technology.

Secondary outcome measures

Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

97%

Neutropenia

94%

Leukopenia

80%

Anemia

76%

Thrombocytopenia

47%

Gastrointestinal

43%

Constitutional

38%

Other Hemotologic

34%

Pain

17%

Infection/Fever

17%

Peripheral neurologic

17%

Pulmonary

14%

Neurologic

11%

Metabolic

10%

2nd Primary

Hepatic

Dermatologic

Cardiovascular

Allergy

Hemorrhage

Genitourinary/Renal

Musculoskeletal

Ocular/Visual

Endocrine

Auditory

Thrombosis/Embolism

Ileus

Infection Documented W Grd 3/4 Neutropn.

Infection Without Neutropenia

Coagulation

Sexual

Platelets

Allergic Reaction/Hypersensitivity

Febrile Neutropenia-Fuo Infect Not Docum

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Gemcitabine - Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Taxol

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device Feasibility (microdevice, surgery)Experimental Treatment13 Interventions

Patients undergo percutaneous implantation of up to 3 drug delivery microdevices up to 2 days before standard of care surgery. Patients receive doxorubicin hydrochloride, ifosfamide, vincristine, irinotecan, temozolomide, pazopanib, everolimus, polyethylene glycol, ganitumab, and temsirolimus via the microdevice in the absence of unacceptable toxicity. At the time of surgery 2 days later, patients have the drug delivery microdevice(s) removed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~7940

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17850

Everolimus

2010

Completed Phase 4

~1510

Pazopanib

2012

Completed Phase 4

~1370

Polyethylene Glycol

2022

Completed Phase 3

~830

Temozolomide

2010

Completed Phase 3

~1930

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9850

Temsirolimus

2008

Completed Phase 2

~1940

Ganitumab

2009

Completed Phase 2

~260

Vincristine

2003

Completed Phase 4

~2910

Irinotecan

2017

Completed Phase 4

~2680

Ifosfamide

2010

Completed Phase 4

~2980

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,968 Previous Clinical Trials

1,786,852 Total Patients Enrolled

55 Trials studying Sarcoma

18,233 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,621 Total Patients Enrolled

453 Trials studying Sarcoma

230,079 Patients Enrolled for Sarcoma

Joseph A LudwigPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Drug Delivery Microdevice (Drug Delivery Device) Clinical Trial Eligibility Overview. Trial Name: NCT04199026 — Phase < 1

Sarcoma Research Study Groups: Device Feasibility (microdevice, surgery)

Sarcoma Clinical Trial 2023: Drug Delivery Microdevice Highlights & Side Effects. Trial Name: NCT04199026 — Phase < 1

Drug Delivery Microdevice (Drug Delivery Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199026 — Phase < 1

Frequently Asked Questions

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

Is this clinical endeavor actively seeking participants?

"This clinical study, which was initially posted in January of 2023 and last updated at the end October 2022 is not currently recruiting. However, there are 2145 other trials enlisting participants presently."

Answered by AI

To what extent has enrollment for this medical experiment been completed?

"At the present time, this particular medical trial is not seeking new patients. It was initially posted on January 31st 2023 and last amended on October 31st 2022. However, those wishing to participate in other studies may be interested to know that 446 clinical trials involving sarcoma are actively recruiting while 1699 research projects related to Therapeutic Conventional Surgery still require participants."

Answered by AI

Has its kind of research been conducted before?

"Globally, there are 1699 active studies evaluating Therapeutic Conventional Surgery in 2965 cities across 75 countries. This research has its roots in a 1997 Phase 3 drug approval trial sponsored by Alfacell, which recruited 300 patients to participate. Since then, 3439 additional trials have been completed."

Answered by AI

Can you tell me about any research conducted to date concerning Therapeutic Conventional Surgery?

"At present, there are 1699 clinical trials related to Therapeutic Conventional Surgery in progress. Of these studies 333 are at the phase 3 level and most of them can be found within Bethesda, Maryland; however, 56616 locations across the globe possess active Therapeutic Conventional Surgery investigations."

Answered by AI