All > Liver Fibrosis > Afinitor

Therapeutic Conventional Surgery for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TXSarcoma+2 MoreTherapeutic Conventional Surgery - Procedure
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Sarcoma
  • Resectable Sarcoma
  • Recurrent Sarcoma
  • Metastatic Sarcoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Cyclophosphamide
1
GROUP D1
1
Isolated Chemotherapeutic Lung Perfusion

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
Determination of the safety and technical feasibility of microdevice insertion/removal, as assessed by adverse events by CTCAE 5.0.
Determine the drug antineoplastic drug effects observed in the adjacent tumor tissues following exposure to drug micro-doses released by each microdevice reservoir.
To assess efficacy across all individual agents or drug combinations tested using the microdevice technology.

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Cyclophosphamide
2
GROUP D1
1
Isolated Chemotherapeutic Lung Perfusion

Side Effects for

Carbo/Topotecan - Carbo/Taxol
98%Neutropenia
92%Leukopenia
76%Anemia
54%Thrombocytopenia
48%Gastrointestinal
43%Constitutional
35%Pain
31%Other Hemotologic
17%Infection/Fever
16%Peripheral neurologic
13%Pulmonary
11%Neurologic
9%Metabolic
9%2nd Primary
6%Dermatologic
5%Endocrine
5%Allergy
5%Hepatic
5%Musculoskeletal
4%Cardiovascular
4%Genitourinary/Renal
3%Ocular/Visual
2%Auditory
2%Hemorrhage
2%Thrombosis/Embolism
2%Coagulation
1%Febrile Neutropenia-Fuo Infect Not Docum
1%Sexual
1%Constipation
1%Infection Without Neutropenia
1%Ileus
1%Vomiting
1%Infection Documented W Grd 3/4 Neutropn.
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00011986) in the Carbo/Topotecan - Carbo/Taxol ARM group. Side effects include: Neutropenia with 98%, Leukopenia with 92%, Anemia with 76%, Thrombocytopenia with 54%, Gastrointestinal with 48%.

Trial Design

1 Treatment Group

Device Feasibility (microdevice, surgery)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · Phase < 1

Device Feasibility (microdevice, surgery)Experimental Group · 13 Interventions: Therapeutic Conventional Surgery, Temsirolimus, Ganitumab, Vincristine, Irinotecan, Doxorubicin, Everolimus, Ifosfamide, Pazopanib, Polyethylene Glycol, Temozolomide, Drug Delivery Microdevice, Doxorubicin Hydrochloride · Intervention Types: Procedure, Drug, Biological, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Sirolimus
FDA approved
Ganitumab
Not yet FDA approved
Vincristine
FDA approved
Irinotecan
FDA approved
Doxorubicin
FDA approved
Everolimus
FDA approved
Ifosfamide
FDA approved
Pazopanib
FDA approved
Polyethylene glycol 400
FDA approved
Temozolomide
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,827 Previous Clinical Trials
1,792,776 Total Patients Enrolled
55 Trials studying Sarcoma
23,876 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,159 Previous Clinical Trials
41,166,961 Total Patients Enrolled
449 Trials studying Sarcoma
236,029 Patients Enrolled for Sarcoma
Joseph A LudwigPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age Any Age · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Therapeutic Conventional Surgery can be employed to treat joints, refractory [ewing sarcoma](https://www.withpower.com/clinical-trials/ewing-sarcoma) and kaposi's sarcoma-related AIDS." - 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.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top