Study of Doxil in the Treatment of Patients With Refracto... | NCT00107913

Studies
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

NCT00107913

Sponsor

Hematology and Oncology Specialists

Status

Unknown status

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Phase 2

Conditions

Autoimmune Thrombocytopenic Purpura

Interventions

Doxil

Countries

United States

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

Status Module

Record Verification Date

Apr 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Apr 2005

First Submitted Date

Apr 11, 2005

First Submission Date that Met QC Criteria

Apr 11, 2005

First Posted Date

Apr 12, 2005Estimated

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

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Description Module

Brief Summary

This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).

Detailed Description

Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Doxil	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the primary outcome would be a platelet response, with a return of platelet count to normal

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
Platelet count of 30,000 or less.
Performance status score of 2 or less.
Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine < 2.
No prior treatment with anthracycline or chemically related drugs.

Exclusion Criteria:

Pregnant or lactating women.
Presence of a malignancy other than basal cell carcinoma of the skin.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas M Cosgriff, MD	Hematology and Oncology Specialists	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology and Oncology Specialists	Recruiting	Metairie	Louisiana	70006	United States

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C506643	liposomal doxorubicin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided