Phase I/II 5-Azacytidine Plus VPA Plus ATRA

This study has been completed.

Study NCT00326170 Information provided by M.D. Anderson Cancer Center

First Received on May 12, 2006. Last Updated on June 6, 2011 History of Changes

Results First Received: June 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Myelodysplastic Syndrome Acute Myelogenous Leukemia
Interventions:	Drug: 5-Azacytidine (5-aza) Drug: Valproic Acid Drug: All-Trans Retinoic Acid (ATRA)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 06/10/05 through 11/17/06. All participants recruited at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The total study recruitment was 55 participants. Phase I completed with 21 participants and recruitment for the Phase II portion was 34 participants.

Reporting Groups

	Description
VPA + 5-aza + ATRA	Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.

Participant Flow: Overall Study

	VPA + 5-aza + ATRA
STARTED	34 ^[1]
COMPLETED	34
NOT COMPLETED	0

[1]	Phase II recruitment

Baseline Characteristics

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Reporting Groups

	Description
VPA + 5-aza + ATRA	Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.

Baseline Measures

	VPA + 5-aza + ATRA
Number of Participants [units: participants]	34
Age [units: years] Median ( Full Range )	71 ( 49 to 84 )
Gender [units: participants]
Female	11
Male	23
Region of Enrollment [units: participants]
United States	34

Outcome Measures

1. Primary:

Number of Participants With Response [ Time Frame: on day 28 of each cycle ]

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2. Primary:

Maximal Tolerated Dose (MTD) [ Time Frame: Routine blood tests (about 1-2 teaspoons each time) 2-3 times a week during study. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org

No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Soriano AO, Yang H, Faderl S, Estrov Z, Giles F, Ravandi F, Cortes J, Wierda WG, Ouzounian S, Quezada A, Pierce S, Estey EH, Issa JP, Kantarjian HM, Garcia-Manero G. Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome. Blood. 2007 Oct 1;110(7):2302-8. Epub 2007 Jun 27.

Responsible Party:	Guillermo Garcia-Manero, MD / Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00326170 History of Changes
Other Study ID Numbers:	2004-0799
Study First Received:	May 12, 2006
Results First Received:	June 6, 2011
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration