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Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy

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ClinicalTrials.gov Identifier: NCT00606216
Recruitment Status : Completed
First Posted : February 1, 2008
Last Update Posted : December 10, 2015
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to learn about possible changes in brain anatomy and in thinking abilities, such as memory skills, in patients with cancer who receive treatment with chemotherapy alone or in combination with total body radiation before undergoing stem cell transplantation.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Acute Undifferentiated Leukemia Biphenotypic Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma Procedure: MRI and cognitive evaluation Procedure: brain MRI study and a brief neuropsychological evaluation

Study Design
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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Structural Imaging and Cognitive Functions in Adult Stem Cell Transplant Recipients Treated With Chemotherapy Alone or in Combination With Radiotherapy
Study Start Date : January 2007
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
A
TBI and Chemotherapy Conditioning Regimen. Twenty (20) patients will undergo conditioning treatment with TBI and chemotherapy prior to receiving a myeloablative allogeneic or an autologous HSCT.
 Procedure: MRI and cognitive evaluation
Patients will undergo a brain MRI study and a brief neuropsychological evaluation, at the time of enrollment for controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients. A follow-up MRI and cognitive evaluation will be performed approximately 12 months after the transplant for patients.
B
Chemotherapy Alone Conditioning Regimen Twenty (20) patients will undergo conditioning treatment with an all chemotherapy regimen prior to receiving an allogeneic or an autologous HSCT.
 Procedure: MRI and cognitive evaluation
Pt will undergo a Magnetic Resonance Imaging (MRI) study of the brain and a brief neuropsychological evaluation, at the time of enrollment for healthy controls and prior to undergoing the conditioning treatment required for the stem cell transplant for patients (Baseline/Time 1).
C
A cohort of twenty (20) healthy controls, frequency matched on age, gender, and education, will be recruited at WCMC to participate in the study.
 Procedure: brain MRI study and a brief neuropsychological evaluation
A brain MRI study and a brief neuropsychological evaluation will be performed at baseline (Time 1). A follow-up MRI and cognitive evaluation will be performed and about 12 months after the baseline for healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. assess changes in hippocampal volume & white matter integrity prospectively in adult ca pts who get treatment w/i chemotherapy alone or in combination with total body irradiation (TBI) before undergoing hematopoietic stem cell transplantation. [ Time Frame: conclusion of the study ]

Secondary Outcome Measures :
  1. assess memory and executive functions prospectively in these patients. We will investigate whether there is an association between structural brain changes and cognitive performance. [ Time Frame: conclusion of the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be identified and recruited to participate in the study by Memorial Sloan-Kettering Cancer Center (MSKCC) and Weill Cornell Medical Center (WCMC).
Criteria

Inclusion Criteria:

  • Diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), acute undifferentiated or biphenotypic leukemia, myelodysplastic syndrome (MDS), Hodgkin's lymphoma, (HL) or non-Hodgkin's lymphoma (NHL), and in complete remission at the time of enrollment
  • Are scheduled to undergo conditioning treatment with (1) total body radiation (TBI) and chemotherapy or (2) chemotherapy alone prior to receiving a myeloablative allogeneic HSCT
  • Between 18 and 70 years of age.
  • Are English speaking.
  • Have capacity to give consent.

Healthy Control Inclusion Criteria:

  • Have no diagnosis of cancer except basal cell carcinoma
  • Between 18 and 70 years of age.
  • Are English speaking.
  • Have capacity to give consent

Exclusion Criteria:

  • Patients with signs and/or symptoms of central nervous system disease as determined by their physician or by a brain MRI, either at the time of enrollment or during the study period.
  • With disease progression at the time of enrollment or during the study period
  • With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
  • With a history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness
  • With standard contraindications to MRI examinations

Healthy Control Exclusion Criteria:

  • Exposure to chemotherapy or radiation therapy for any medical condition
  • With self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia
  • With a history of neurological disorders, neurodegenerative disease, or traumatic brain injury with loss of consciousness
  • With standard contraindications to MRI examinations
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606216


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical Center
New York, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Denise Correa, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00606216    
Other Study ID Numbers: 06-162
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
MRI
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
 Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid