TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma... | NCT00289809

Studies
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients

NCT00289809

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Dec 18, 2009Estimated

Enrollment

36Estimated

Phase

Phase 1Phase 2

Conditions

Sarcoma, Soft Tissue

Interventions

combination of TLC D-99 and Ifosfamide

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT 2005-004569-40

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Feb 9, 2006

First Submission Date that Met QC Criteria

Feb 9, 2006

First Posted Date

Feb 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2009

Last Update Posted Date

Dec 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

Detailed Description

The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.

Then, Phase II study started.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
combination of TLC D-99 and Ifosfamide	Drug	TLC D-99: 40 mg/m2 Day 1 every 3 weeks; Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide		Definition of TDL
Phase II: Response rate (CR/PR or SD)		Tumor assessment

Secondary Outcomes

Measure	Description	Time Frame
Phase II: time to progression, duration of response, overall survival		Tumor assessment, follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
Age >/=18 yrs
PS </=2
Disease detectable almost for 1 dimension
Life expectancy >/=3 mos
Minimum 4 wks from last radiotherapy
Adequate medullary, liver, and renal functions
Normal LVEF
Written Informed Consent

Exclusion Criteria:

Pregnant or breast-feeding patients
Serious concomitant disease or not controlled infections

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armando Santoro, MD	Istituto Clinico Humanitas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinico Humanitas		Rozzano	Milan	20089	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007069	Ifosfamide

Ancestor Terms

ID	Term
D003520	Cyclophosphamide
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds

Browse Leaves

Not provided

Browse Branches

Not provided