Captopril in Treating Patients Undergoing Bone Marrow or... | NCT00004230 | Trialant
NCT00004230
Sponsor
Northwestern University
Status
Completed
Last Update Posted
Jun 6, 2012Estimated
Enrollment
35Actual
Phase
Phase 3
Conditions
Cancer
Interventions
captopril
cyclophosphamide
autologous bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Countries
United States
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
NCT00004230
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NU 98CC1
Secondary IDs
ID
Type
Description
Link
NU-98CC1
NCI-G99-1658
Brief Title
Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation
Official Title
Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation
Acronym
Not provided
Organization
Northwestern UniversityOTHER
Status Module
Record Verification Date
May 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 1999
Primary Completion Date
Mar 2002Actual
Completion Date
Mar 2002Actual
First Submitted Date
Jan 28, 2000
First Submission Date that Met QC Criteria
Apr 30, 2004
First Posted Date
May 3, 2004Estimated
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
Feb 16, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 16, 2011
Certification/Extension First Posted Date
Feb 18, 2011Estimated
Last Update Submitted Date
May 31, 2012
Last Update Posted Date
Jun 6, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Northwestern UniversityOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Captopril may protect the lungs from the side effects of bone marrow or stem cell transplantation.
PURPOSE: Randomized phase III trial to determine the effectiveness of captopril to lessen the side effects in patients who are undergoing bone marrow or stem cell transplantation following chemotherapy and radiation therapy.
Detailed Description
OBJECTIVES: I. Determine if captopril can block or prevent lung injury in patients undergoing autologous bone marrow or stem cell transplantation following cyclophosphamide and total body radiotherapy or high dose chemotherapy. II. Determine a series of surrogate lung injury prediction markers for monitoring patients undergoing therapy.
OUTLINE: This is a randomized study. Patients are stratified according to preparative regimen (high dose chemotherapy versus cyclophosphamide and total body radiotherapy). Patients are randomized into one of two treatment arms. All patients undergo a conditioning regimen consisting of cyclophosphamide daily on days -6 and -5 and total body radiotherapy on day -4 through -1, or high dose chemotherapy per transplantation protocol. Arm I: Patients receive oral captopril 2 to 3 times daily beginning on the first day of the conditioning regimen and continuing until day 100 post autologous bone marrow or stem cell transplantation. Arm II: Patients receive no captopril while undergoing conditioning therapy. Patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
pulmonary complications
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
recurrent childhood acute lymphoblastic leukemia
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
recurrent childhood rhabdomyosarcoma
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
disseminated neuroblastoma
recurrent neuroblastoma
recurrent Wilms tumor and other childhood kidney tumors
stage I multiple myeloma
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
35Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
captopril
Drug
cyclophosphamide
Drug
autologous bone marrow transplantation
Procedure
peripheral blood stem cell transplantation
Procedure
radiation therapy
Radiation
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS: Eligible for existing autologous bone marrow or stem cell transplantation protocols using either a high dose chemotherapy regimen or a cyclophosphamide and total body radiotherapy regimen
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other concurrent medical illness that would preclude study
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior captopril or other ACE inhibitors
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Leo I. Gordon, MD
Robert H. Lurie Cancer Center
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago
Illinois
60611
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D001943
Breast Neoplasms
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D006689
Hodgkin Disease
D016410
Lymphoma, T-Cell, Cutaneous
D009101
Multiple Myeloma
D000077216
Carcinoma, Ovarian Epithelial
D009447
Neuroblastoma
D009396
Wilms Tumor
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D015470
Leukemia, Myeloid, Acute
D013736
Testicular Neoplasms
D015466
Leukemia, Myeloid, Chronic-Phase
D015465
Leukemia, Myeloid, Accelerated Phase
D001752
Blast Crisis
D055728
Primary Myelofibrosis
C562472
Teratoma, Testicular
D018240
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D002216
Captopril
D003520
Cyclophosphamide
D036102
Peripheral Blood Stem Cell Transplantation
D011878
Radiotherapy
Ancestor Terms
ID
Term
D011392
Proline
D007098
Imino Acids
D000598
Amino Acids, Cyclic
D000596
Amino Acids
Browse Leaves
Not provided
Browse Branches
Not provided
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent childhood acute myeloid leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
chronic idiopathic myelofibrosis
childhood acute promyelocytic leukemia (M3)
testicular embryonal carcinoma
testicular choriocarcinoma
testicular teratoma
testicular yolk sac tumor
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and seminoma
refractory hairy cell leukemia
recurrent/refractory childhood Hodgkin lymphoma
recurrent ovarian germ cell tumor
ovarian yolk sac tumor
ovarian embryonal carcinoma
ovarian polyembryoma
ovarian choriocarcinoma
ovarian immature teratoma
ovarian mature teratoma
ovarian monodermal and highly specialized teratoma
ovarian mixed germ cell tumor
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma