Tamibarotene and Arsenic Trioxide for Relapsed Acute Prom... | NCT00985530

Studies
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

NCT00985530

Sponsor

Northwestern University

Status

Terminated

Last Update Posted

Oct 30, 2013Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Acute Promyelocytic Leukemia

Interventions

Tamibarotene
Arsenic trioxide

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

ID	Type	Description	Link
NCI-2010-01852	Other Identifier	NCI CTRP#
STU00012159	Other Identifier	Northwestern University IRB#

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Supporting agency withdrew funding for study.

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Sep 25, 2009

First Submission Date that Met QC Criteria

Sep 25, 2009

First Posted Date

Sep 28, 2009Estimated

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

Oct 28, 2013

Last Update Posted Date

Oct 30, 2013Estimated

Name	Class
CytRx	INDUSTRY
Cephalon	INDUSTRY

Description Module

Brief Summary

Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Tamibarotene + Arsenic Trioxide	Drug: Tamibarotene Drug: Arsenic trioxide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tamibarotene	Drug	Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.		Once the MTD has been reached.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must have diagnosis of relapsed APL
Must have completed any prior cancer treatment at least 6 months prior to study
Must have had prior treatment that included ATRA

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

Condition Browse Module

MeSH Terms

ID	Term
D015473	Leukemia, Promyelocytic, Acute

Ancestor Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C061133	tamibarotene
D000077237	Arsenic Trioxide

Ancestor Terms

ID	Term
D001152	Arsenicals
D007287	Inorganic Chemicals
D010087	Oxides
D017601	Oxygen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided