Neoplasms

All Conditions

Rare Diseases

Liposarcoma

Liposarcoma, Myxoid

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Myxoid Liposarcoma

Soft Tissue Sarcoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Trabectedin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion.

Trabectedin 1.5 mg/m\^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.

Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m\^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.

Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma

A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.

The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

PharmaMar

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Trabectedin at a dose of 1.5 milligram per meter square (mg/m\^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.

18-49 years

50-69 years

greater than or equal to 70 years

Age, Customized

Sex: Female, Male

Medical Specialist, Clinical Oncology

Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment.

Percentage of Participants With Pathological Complete Response (pCR)

Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma	NCT00579501	Liposarcoma,Myx...	Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma	NCT00579501	Liposarcoma,Myx...	Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma	NCT00579501	Liposarcoma,Myx...	Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Spots Global Cancer Trial Database for liposarcoma,myxoid