Learning Impairments Among Survivors of Childhood Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

St. Jude Children's Research Hospital

ClinicalTrials.gov Identifier:

NCT00576472

First received: December 17, 2007

Last updated: February 11, 2013

Last verified: August 2012

History of Changes

Results First Received: October 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
Conditions:	Acute Lymphoblastic Leukemia Brain Tumors
Intervention:	Drug: Methylphenidate

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
505 patients were enrolled from 3 institutions between January, 2000 and February, 2009. 91 siblings were enrolled as a control group.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 505 patients enrolled on the study, 36 were never assessed, and 469 participated in the initial screening. Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day MPH In-Lab Phase.

Reporting Groups

	Description
Mild Intensity	Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
Moderate Intensity	Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
High Intensity	Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase	Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
Group M/P	Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
Group P/M	Group P/M (patients received oral placebo and then Methylphenidate (MPH))
Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase	Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
Placebo/Low Dose/Moderate Dose (PLM)	The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Placebo/Moderate Dose/Low Dose (PML)	The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
Low Dose/Moderate Dose/ Placebo (LMP)	The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Low Dose/Placebo/Moderate Dose (LPM)	The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Moderate Dose/Low Dose/Placebo (MLP)	The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Moderate Dose/Placebo/Low Dose (MPL)	The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
Declined Methylphenidate (MPH) Home Maintenance Phase	Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
Methylphenidate (MPH) Home Maintenance Phase	Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.

Participant Flow for 4 periods

Period 1: Initial Screening

	Mild Intensity	Moderate Intensity	High Intensity
STARTED	230	40	199
COMPLETED	230	40	199
NOT COMPLETED	0	0	0

Period 2: MPH In-Lab Phase

	Mild Intensity	Moderate Intensity	High Intensity	Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase	Group M/P	Group P/M
STARTED	0 ^[1]	0 ^[1]	0 ^[1]	335	67	67
COMPLETED	0	0	0	0	67	67
NOT COMPLETED	0	0	0	335	0	0
Declined participation in medication pha	0	0	0	75	0	0
Lost to Follow-up	0	0	0	1	0	0
Patients did not qualify - IQ < 50	0	0	0	4	0	0
No attention/academic problems	0	0	0	245	0	0
Psychiatric exclusion	0	0	0	10	0	0

[1]	Group only associated with Screening phase.

Period 3: MPH Cross Over Phase

	Mild Intensity	Moderate Intensity	High Intensity	Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase	Group M/P	Group P/M	Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase	Placebo/Low Dose/Moderate Dose (PLM)	Placebo/Moderate Dose/Low Dose (PML)	Low Dose/Moderate Dose/ Placebo (LMP)	Low Dose/Placebo/Moderate Dose (LPM)	Moderate Dose/Low Dose/Placebo (MLP)	Moderate Dose/Placebo/Low Dose (MPL)
STARTED	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	12	20	18	22	23	18	21
COMPLETED	0	0	0	0	0	0	0	20	16	22	22	17	21
NOT COMPLETED	0	0	0	0	0	0	12	0	2	0	1	1	0
Withdrawal by Subject	0	0	0	0	0	0	6	0	0	0	0	0	0
Ineligible due to disease	0	0	0	0	0	0	2	0	0	0	0	0	0
Physician Decision	0	0	0	0	0	0	4	0	0	0	0	0	0
Did not complete cross over phase	0	0	0	0	0	0	0	0	2	0	1	1	0

[1]	Group not associated with MPH Cross-over phase.

Period 4: MPH Home Maintenance Phase

	Mild Intensity	Moderate Intensity	High Intensity	Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase	Group M/P	Group P/M	Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase	Placebo/Low Dose/Moderate Dose (PLM)	Placebo/Moderate Dose/Low Dose (PML)	Low Dose/Moderate Dose/ Placebo (LMP)	Low Dose/Placebo/Moderate Dose (LPM)	Moderate Dose/Low Dose/Placebo (MLP)	Moderate Dose/Placebo/Low Dose (MPL)	Declined Methylphenidate (MPH) Home Maintenance Phase	Methylphenidate (MPH) Home Maintenance Phase
STARTED	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	0 ^[1]	27	91
COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	68
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	27	23
Did not meet response criteria	0	0	0	0	0	0	0	0	0	0	0	0	0	16	0
Declined to participate	0	0	0	0	0	0	0	0	0	0	0	0	0	7	0
Insufficient data	0	0	0	0	0	0	0	0	0	0	0	0	0	4	0
Side effects	0	0	0	0	0	0	0	0	0	0	0	0	0	0	8
Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6
Medical reasons	0	0	0	0	0	0	0	0	0	0	0	0	0	0	6
Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3

[1]	Group not associated with Home Maintenance Phase.

Baseline Characteristics

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Reporting Groups

	Description
Mild	Intensity of prior Central Nervous System radiation therapy was considered mild.
Moderate	Intensity of prior Central Nervous System radiation therapy was considered moderate.
High	Intensity of prior Central Nervous System radiation therapy was considered high.
Not Randomized-In Lab Phase	Patients not randomized for the MPH in Lab Phase
Group M/P	Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
Group P/M	Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
Not Randomized-Cross Over	Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
Placebo/Low Dose/Moderate Dose (PLM)	The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Placebo/Moderate Dose/Low Dose (PML)	The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
Low Dose/Moderate Dose/ Placebo (LMP)	The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Low Dose/Placebo/Moderate Dose (LPM)	The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
Moderate Dose/Low Dose/Placebo (MLP)	The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
Moderate Dose/Placebo/Low Dose (MPL)	The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
Declined Home Maintenance Phase	Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
Home Maintenance Phase	Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
Total	Total of all reporting groups

Baseline Measures

	Mild	Moderate	High	Not Randomized-In Lab Phase	Group M/P	Group P/M	Not Randomized-Cross Over	Placebo/Low Dose/Moderate Dose (PLM)	Placebo/Moderate Dose/Low Dose (PML)	Low Dose/Moderate Dose/ Placebo (LMP)	Low Dose/Placebo/Moderate Dose (LPM)	Moderate Dose/Low Dose/Placebo (MLP)	Moderate Dose/Placebo/Low Dose (MPL)	Declined Home Maintenance Phase	Home Maintenance Phase	Total
Number of Participants [units: participants]	230	40	199	0	0	0	0	0	0	0	0	0	0	0	0	469
Age, Customized [units: Participants]
< 4 years of age	113	23	51													187
≥ 4 years of age	117	17	148													282
Gender [units: participants]
Female	98	16	90													204
Male	132	24	109													265
Disease Group [units: Participants]
Acute Lymphoblastic Leukemia (ALL)	216	39	3													258
Brain Tumors (BT)	14	1	196													211

Outcome Measures

Show All Outcome Measures

1. Primary:

Brain White Matter Volume for Patients Versus Sibling Controls [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

Show Outcome Measure 1

2. Primary:

Brain White Matter Volume for Patients With Acute Lymphoblastic Leukemia Versus Brain Tumors [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

Show Outcome Measure 2

3. Primary:

Brain White Matter Volume for Treatment Intensity Groups and Sibling Controls [ Time Frame: Enrollment to evaluation of MRI, on average 12.8 months. ]

Show Outcome Measure 3

4. Primary:

Change From Methylphenidate (MPH) Home Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: ADHD T Score) [ Time Frame: From beginning and at completion of Methylphenidate (MPH) Home Maintenance Phase, on average 16.3 months. ]

Show Outcome Measure 4

5. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Teacher Rating Scale (CTRS: Cognitive Problem T Score) [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 5

6. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 6

7. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Conner's Parent Rating Scale (CPRS: Cognitive Problem T Score) [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 7

8. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Social Skill Rating System (SSRS-P) [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 8

9. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Reading: Composite Standard Score [ Time Frame: From beginning and at completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 9

10. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Spelling: Standard Score [ Time Frame: From beginning and after completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 10

11. Primary:

Change From Maintenance Phase Baseline to Completion of Phase as Measured by Wechsler Individual Achievement Test (WIAT) Math: Composite Standard Score [ Time Frame: From beginning and after completion of home maintenance phase, on average 16.3 months. ]

Show Outcome Measure 11

12. Secondary:

Best Weekly Score Measured by Conners' Parent Rating Scale (CPRS: ADHD T Score) During the 3-week Home Crossover Phase. [ Time Frame: weekly during 3-week home crossover phase ]

Show Outcome Measure 12

13. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Cognitive Problem/Inattention Scale. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 13

14. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) Hyperactivity Scale. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 14

15. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Parent Rating Scale (CPRS) ADHD Index. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 15

16. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Cognitive Problem/Inattention Scale. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 16

17. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) Hyperactivity Scale. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 17

18. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by The Conners’ Teacher Rating Scale (CTRS) ADHD Index. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks ]

Show Outcome Measure 18

19. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Social Skill. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 19

20. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Parent (SSRS-P) – Problem Behavior. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 20

21. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Social Skill. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 21

22. Secondary:

Effectiveness of MPH in Enhancing Classroom Attentiveness, Academic Productivity, and Social Behavior Measured by Social Skills Rating System - Teacher (SSRS-T) – Problem Behavior. [ Time Frame: Evaluated at the end of each medication week during the Home Therapy Phase- placebo, low dose and moderate dose weeks. ]

Show Outcome Measure 22

23. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Omission Errors. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 23

24. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for Commission Errors. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 24

25. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Hit Reaction Time. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 25

26. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner's Continuous Performance Test (CPT) for d’ (Sensitivity). [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 26

27. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Sustained Attention, Reaction Time, and, Impulsivity Using Conner’s Continuous Performance Test (CPT) for Beta (Risk Taking). [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 27

28. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) Over Five Learning Trials. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 28

29. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Short Delay Free Recall. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 29

30. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Learning and Recall Using California Verbal Learning Test (CVLT) for Long Delay Free Recall. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 30

31. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Word Naming Time. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 31

32. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Color Naming Time. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 32

33. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Ink Color Naming Time. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 33

34. Secondary:

Establish the Effectiveness of MPH on Laboratory Measures of Interference, Impulsivity, Cognitive Flexibility, and Selective Attention Using the Stroop Word-Color Association Test (Stroop) for Interference Score. [ Time Frame: Subjects were tested in both the drug and placebo groups before and after taking either MPH or placebo. ]

Show Outcome Measure 34

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
No text entered.

Results Point of Contact:

Name/Title: Heather Conklin PhD
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org

Publications:

Mulhern RK, Khan RB, Kaplan S, Helton S, Christensen R, Bonner M, Brown R, Xiong X, Wu S, Gururangan S, Reddick WE. Short-term efficacy of methylphenidate: a randomized, double-blind, placebo-controlled trial among survivors of childhood cancer. J Clin Oncol. 2004 Dec 1;22(23):4795-803. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248.

Reddick WE, Shan ZY, Glass JO, Helton S, Xiong X, Wu S, Bonner MJ, Howard SC, Christensen R, Khan RB, Pui CH, Mulhern RK. Smaller white-matter volumes are associated with larger deficits in attention and learning among long-term survivors of acute lymphoblastic leukemia. Cancer. 2006 Feb 15;106(4):941-9.

Conklin HM, Khan RB, Reddick WE, Helton S, Brown R, Howard SC, Bonner M, Christensen R, Wu S, Xiong X, Mulhern RK. Acute neurocognitive response to methylphenidate among survivors of childhood cancer: a randomized, double-blind, cross-over trial. J Pediatr Psychol. 2007 Oct;32(9):1127-39. Epub 2007 Jun 14.

Reeves CB, Palmer S, Gross AM, Simonian SJ, Taylor L, Willingham E, Mulhern RK. Brief report: sluggish cognitive tempo among pediatric survivors of acute lymphoblastic leukemia. J Pediatr Psychol. 2007 Oct;32(9):1050-4. Epub 2007 Oct 12.

Publications automatically indexed to this study:

Conklin HM, Lawford J, Jasper BW, Morris EB, Howard SC, Ogg SW, Wu S, Xiong X, Khan RB. Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial. Pediatrics. 2009 Jul;124(1):226-33.

Responsible Party:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00576472 History of Changes
Other Study ID Numbers:	MEMFX2, RO1-CA078957, UO1-CA81445, P30-CA2Z1765
Study First Received:	December 17, 2007
Results First Received:	October 28, 2011
Last Updated:	February 11, 2013
Health Authority:	United States: Institutional Review Board

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