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

Sarcoma, Soft Tissue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289809
• Other study ID #: ONC-2005-001
• Secondary ID: EUDRACT 2005-004
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 9, 2006
• Last updated: December 17, 2009
• Start date: September 2006
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

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

Then, Phase II study started.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• combination of TLC D-99 and Ifosfamide
TLC D-99: 40 mg/m2 Day 1 every 3 weeks; Ifosfamide: 3000 mg/m2 Day 1, 2, 3 every 3 weeks

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide		Definition of TDL	Yes
Primary	Phase II: Response rate (CR/PR or SD)		Tumor assessment	Yes
Secondary	Phase II: time to progression, duration of response, overall survival		Tumor assessment, follow-up	Yes