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

Primary Purpose

Liposarcoma,Myxoid

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Trabectedin
Dexamethasone
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liposarcoma,Myxoid focused on measuring Myxoid, Liposarcoma, Trabectedin, Dexamethasone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies
  • Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery
  • Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST])
  • No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

Exclusion Criteria:

  • Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone
  • Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods
  • History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer
  • Known distant metastases
  • Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trabectedin

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Pathological Complete Response (pCR)
Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.

Secondary Outcome Measures

Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)
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.

Full Information

First Posted
December 20, 2007
Last Updated
April 22, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PharmaMar
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1. Study Identification

Unique Protocol Identification Number
NCT00579501
Brief Title
Safety and Efficacy Study of Trabectedin for the Treatment of Localized Myxoid / Round Cell Liposarcoma
Official Title
A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
PharmaMar

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liposarcoma,Myxoid
Keywords
Myxoid, Liposarcoma, Trabectedin, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trabectedin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion
Primary Outcome Measure Information:
Title
Percentage of Participants With Pathological Complete Response (pCR)
Description
Complete pathological response is complete disappearance of the tumor tissue up to the molecular level.
Time Frame
Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST)
Description
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.
Time Frame
Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathological diagnosis of myxoid / round cell liposarcoma (MRCL) and availability of pathology specimens for central review and pharmacogenomic studies Clinical evidence of locally advanced (Stage III), non-metastatic tumor, including locally recurring disease after initial surgery Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST]) No prior chemotherapy or radiation (except for adjuvant post-operative radiotherapy) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 Exclusion Criteria: Known hypersensitivity to any of the components of the trabectedin intravenous (iv) formulation or dexamethasone Pregnant or lactating women and women of reproductive potential who are not using effective contraceptive methods History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 5 years or longer Known distant metastases Other serious illnesses such as congestive heart failure or angina pectoris, myocardial infarction within 1 year before enrollment, uncontrolled arterial hypertension or arrhythmias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Coeur D Alene
State/Province
Idaho
Country
United States
City
Park Ridge
State/Province
Illinois
Country
United States
City
Iowa City
State/Province
Iowa
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Bourdeaux
Country
France
City
Lyon
Country
France
City
Villejuif
Country
France
City
Mannheim
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21642514
Citation
Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Perez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3.
Results Reference
derived

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

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