Captopril in Treating Patients Undergoing Bone Marrow or Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00004230
First received: January 28, 2000
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: captopril
Drug: cyclophosphamide
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Phase III Study of Captopril in Patients Undergoing Autologous Bone Marrow/Stem Cell Transplantation

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Lymphoma, Small Cleaved-cell, Diffuse Testicular Cancer Ovarian Epithelial Cancer Multiple Myeloma Acute Lymphoblastic Leukemia Leukemia, Myeloid Chronic Myeloid Leukemia Myelodysplastic Syndromes Hodgkin Lymphoma Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Neuroblastoma Acute Myeloid Leukemia, Adult Follicular Lymphoma Hodgkin Lymphoma, Childhood B-cell Lymphomas Myelofibrosis Burkitt Lymphoma Choriocarcinoma Yolk Sac Tumor Lymphoma, Large-cell Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Lymphoblastic Lymphoma Small Non-cleaved Cell Lymphoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Kidney Cancer Renal Cancer Acute Lymphoblastic Leukemia, Childhood Wilms' Tumor Acute Myeloid Leukemia, Childhood Acute Promyelocytic Leukemia Mantle Cell Lymphoma Cutaneous T-cell Lymphoma Gestational Trophoblastic Tumor Ovarian Germ Cell Tumor Hairy Cell Leukemia Mycosis Fungoides Sezary Syndrome Seminoma Embryonal Carcinoma Polyembryoma
U.S. FDA Resources

Further study details as provided by Northwestern University:

Enrollment: 35
Study Start Date: October 1999
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004230

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Leo I. Gordon, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00004230     History of Changes
Other Study ID Numbers: NU 98CC1, NU-98CC1, NCI-G99-1658
Study First Received: January 28, 2000
Last Updated: May 31, 2012
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
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
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Captopril
Cyclophosphamide
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on August 01, 2014