NCT00289809

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 18, 2009

Status Verified

December 1, 2009

Enrollment Period

3.3 years

First QC Date

February 9, 2006

Last Update Submit

December 17, 2009

Conditions

Sarcoma, Soft Tissue

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

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

    Tumor assessment, follow-up

Interventions

combination of TLC D-99 and IfosfamideDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 18, 2009

Record last verified: 2009-12

Locations

IT(1)