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Drug Delivery Device

Drug Delivery Microdevice for Sarcoma

Phase < 1

Waitlist Available

Led By Joseph Ludwig, MD

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

Must not have

Age < 10 years old

Subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My sarcoma has returned or spread and surgery is recommended.

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

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I am at least 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 10 years old.

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I do not want or cannot have surgery for my condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

95%

Neutropenia

87%

Leukopenia

59%

Anemia

49%

Gastrointestinal

42%

Constitutional

37%

Thrombocytopenia

37%

Pain

24%

Peripheral neurologic

19%

Other Hemotologic

16%

Infection/Fever

14%

Neurologic

14%

Metabolic

12%

Pulmonary

Allergy

2nd Primary

Dermatologic

Musculoskeletal

Cardiovascular

Ocular/Visual

Hepatic

Genitourinary/Renal

Endocrine

Auditory

Hemorrhage

Thrombosis/Embolism

Febrile Neutropenia-Fuo Infect Not Docum

Constipation

Syncope

Vomiting

Abdominal Pain Or Cramping

Infection Documented W Grd 3/4 Neutropn.

Ileus

Coagulation

Allergy-Other

Allergic Reaction/Hypersensitivity

Infection Without Neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Gemcitabine - Carbo/Taxol

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~8030

Doxorubicin Hydrochloride

2019

Completed Phase 3

~17860