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Follow-Up of Patients With Breast Cancer or Multiple Myeloma Previously Treated on a Gene Therapy Clinical Trial

This study is ongoing, but not recruiting participants.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00427726
  Purpose

RATIONALE: Studying the long-term effects of gene therapy in patients with breast cancer or multiple myeloma over time may help doctors plan better treatment and follow-up.

PURPOSE: This natural history study is collecting health information from patients with breast cancer or multiple myeloma previously treated on a gene therapy clinical trial.


Condition Intervention
Breast Cancer
Multiple Myeloma and Plasma Cell Neoplasm
Procedure: laboratory biomarker analysis
Procedure: molecular genetic technique

Genetics Home Reference related topics:   aceruloplasminemia    breast cancer    hemophilia   

MedlinePlus related topics:   Breast Cancer    Cancer    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Follow-Up Study Of Breast Cancer And Multiple Myeloma Subjects Previously Enrolled In Retroviral Gene Transfer Studies

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Provide a mechanism for adequate follow-up of patients

Estimated Enrollment:   13
Study Start Date:   March 2003

Detailed Description:

OBJECTIVES:

  • Provide a mechanism for adequate follow-up of patients previously treated for breast cancer or multiple myeloma on a retroviral gene transfer study.

OUTLINE: Patients are contacted to update health status and collect blood samples every 6 months for 5 years and then annually for at least 10 years. Blood samples are tested for presence of retroviral gene transfer vector and replication competent retrovirus.

PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Received gene transfer products while enrolled in 1 of the following clinical trials for the treatment of breast cancer or multiple myeloma:

    • NCI-96-C-0007K
    • NCI-92-C-0161I
    • NCI-93-C-0208I
    • NHLBI-92-H-57
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • Any age (as per individual clinical trial)

Sex

  • As per individual clinical trial

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent participation on a treatment or continuing care clinical trial allowed
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427726

Sponsors and Collaborators

Investigators
Study Chair:     Michael R. Bishop, MD     National Cancer Institute (NCI)    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000299050, NCI-03-C-0124
First Received:   January 25, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00427726
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma  
stage II multiple myeloma  
stage III multiple myeloma  
recurrent breast cancer  
stage IV breast cancer
male breast cancer
refractory plasma cell neoplasm

Study placed in the following topic categories:
Immunoproliferative Disorders
Skin Diseases
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Breast Neoplasms
Paraproteinemias
Hemostatic Disorders
Recurrence
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Breast Neoplasms, Male
Lymphoproliferative Disorders
Breast Diseases
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008




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