Back to results

Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Primary Purpose

Acute Promyelocytic Leukemia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Tamibarotene

Arsenic trioxide

About this trial

This is an interventional treatment trial for Acute Promyelocytic Leukemia

Eligibility Criteria

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

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

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Tamibarotene + Arsenic Trioxide

Outcomes

Primary Outcome Measures

To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.

Secondary Outcome Measures

Full Information

NCT ID

NCT00985530

First Posted

September 25, 2009

Last Updated

October 28, 2013

Sponsor

Northwestern University

Collaborators

CytRx, Cephalon

1. Study Identification

Unique Protocol Identification Number

NCT00985530

Brief Title

Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Official Title

A Phase I Trial of Tamibarotene and Arsenic Trioxide for the Treatment of Relapsed Acute Promyelocytic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

Supporting agency withdrew funding for study.

Study Start Date

October 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

CytRx, Cephalon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Acute Promyelocytic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Tamibarotene + Arsenic Trioxide

Intervention Type

Drug

Intervention Name(s)

Tamibarotene

Intervention Description

Self-administered tablets BID (approximately one hour after breakfast & dinner) during each 6 week cycle

Intervention Type

Drug

Intervention Name(s)

Arsenic trioxide

Intervention Description

Administered intravenously Monday thru Friday at 0.15 mg/kg - 30 doses per cycle.

Primary Outcome Measure Information:

Title

To determine the safety and feasibility of combining tamibarotene and arsenic (ATO) for the treatment of patients with relapsed APL.

Time Frame

Once the MTD has been reached.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

We'll reach out to this number within 24 hrs