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

Primary Purpose

Sarcoma, Soft Tissue

Status

Completed

Phase

Phase 1

Locations

Italy

Study Type

Interventional

Intervention

combination of TLC D-99 and Ifosfamide

About this trial

This is an interventional treatment trial for Sarcoma, Soft Tissue

Eligibility Criteria

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

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

Sites / Locations

Istituto Clinico Humanitas

Outcomes

Primary Outcome Measures

Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide

Phase II: Response rate (CR/PR or SD)

Secondary Outcome Measures

Phase II: time to progression, duration of response, overall survival

Full Information

NCT ID

NCT00289809

First Posted

February 9, 2006

Last Updated

December 17, 2009

Sponsor

Istituto Clinico Humanitas

1. Study Identification

Unique Protocol Identification Number

NCT00289809

Brief Title

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

Official Title

A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Soft Tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

combination of TLC D-99 and Ifosfamide

Intervention Description

TLC D-99: 40 mg/m2 Day 1 every 3 weeks; Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks

Primary Outcome Measure Information:

Title

Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide

Time Frame

Definition of TDL

Title

Phase II: Response rate (CR/PR or SD)

Time Frame

Tumor assessment

Secondary Outcome Measure Information:

Title

Phase II: time to progression, duration of response, overall survival

Time Frame

Tumor assessment, follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Armando Santoro, MD

Organizational Affiliation

Istituto Clinico Humanitas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Clinico Humanitas

City

Rozzano

State/Province

Milan

ZIP/Postal Code

20089

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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