Protocol Number: 00-C-0078

Title:

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples from Patients with Cancer

Number:

00-C-0078

Summary:

This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients' tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.

Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.

Patients with malignancy are eligible.

Patients requiring a surgical procedure for any medical indication can be included on study.

Patients requiring biopsy or any procedure for any medical indication can be included on study.

Patients not requiring biopsy for a medical indication can be included solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples, providing the biopsy or aspiration procedure is of minimal risk, i.e., fine needle aspirate, bone marrow aspirate, or excisional biopsy.

EXCLUSION CRITERIA:

Pregnant patients will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.

HIV patients will not be eligible since the immunodeficiency may put them at greater risk from complications due to the procedures involved in obtaining the biopsies.

Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.

Special Instructions: Currently Not Provided

Keywords:

Resistance

Malignant

Biopsy Samples

Specimen Acquisition

Cancer Cells

Recruitment Keywords:

None

Conditions:

Neoplasm

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Efflux of rhodamine from CD56+ cells as a surrogate marker for reversal of P-glycoprotein -mediated drug efflux by PSC 833

Molecular cloning of cDNAs which are highly overexpressed in mitoxantrone-resistant cells: demonstration of homology of ABC transport genes

Downregulation of mdr-1 expression by 8-Cl-cAMP in multidrug resistant MCF-7 human breast cancer cells

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004