Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance

NCT ID: NCT00026663

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2000-08-09
• Study Completion Date: 2024-06-28

Brief 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.

Detailed Description

Background:

Ongoing research in the Molecular Pharmacology Section, NCI, requires the availability of blood, fluid, bone marrow, tumor, hair follicle and tissue samples from patients with cancer. Resistance is the underlying cause of treatment failure, and may present as acquired or intrinsic drug resistance. Patients with cancer frequently present with chemotherapy-responsive disease, and undergo tumor response, only to eventually experience relapse, at which time the tumor may be refractory to further treatment. This is termed acquired drug resistance; while intrinsic resistance implies a cancer that is refractory from the outset. Diverse mechanisms of drug resistance have been described and are often dependent upon the particular drug under study.

Objectives:

To obtain blood, fluid, hair follicles, bone marrow, tumor and/or normal tissue samples that would allow development of assays for use in subsequent clinical trials.

Eligibility:

Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be evaluated in the GMB Clinic, NCI.

Participants may be on, or in the process of being evaluated for a research protocol. Participants may receive treatment on the standard care protocol.

Normal volunteers may enroll in the study.

Design:

Acquired samples will be recorded in the computerized data bank currently existing in the Molecular Pharmacology Section. No germline testing will be performed on any of the samples collected. Tests will be pilot studies relating to the Section s work on the biology of drug resistance and cell survival in cancer.

Sample collection for patients with cancer:

• Blood samples, fluid samples, or hair follicle samples may be collected at the initial visit, and at follow up visits.
• Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, providing the tumor is accessible.
• Bone marrow aspirate, thoracentesis, and paracentesis may be performed.

Normal volunteers may enroll in the study for collection of blood, fluid, and/or hair follicle samples.

Examples of the types of studies to be performed with biopsies will be drug resistance gene expression assays, with the goal of demonstrating the utility of the assay in participant samples.

Evaluation of methods to detect drug resistance proteins and genes will be explored, including Northern blot, immunoblot, polymerase chain reaction assay, and RNA in situ hybridization. With whole blood, we may evaluate the presence of dye transport in an ex vivo assay, for example, using inhibitors of ABCG2. Evidence of drug accumulation or DNA damage may be sought in participant mononuclear cells or in hair follicle samples.

Conditions

Renal Cell Carcinoma; Lung Carcinoma; Cervical Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1/Patients with cancer

Cancer patients providing tissue for research studies

No interventions assigned to this group

2/Normal Volunteers

normal volunteers providing samples for research studies

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Participants 18 years of age and older are eligible.

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

3. Participants with malignancy are eligible.

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

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

6. Participants not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples. No radiology tests will be used in the procedure to collect a sample that would not be otherwise used for an appropriate medical indication.

7. Normal volunteers 18 years of age and older are eligible to enroll. Normal volunteers must be willing to sign informed consent and must be willing to provide samples to be used for research.

Exclusion Criteria

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

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

3. Normal volunteers with a history of a clotting disorder may not enroll.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William D Figg, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2000-C-0078.html

NIH Clinical Center Detailed Web Page

Other Identifiers

00-C-0078

Identifier Type: -

Identifier Source: secondary_id

000078

Identifier Type: -

Identifier Source: org_study_id

NCT00919529

Identifier Type: -

Identifier Source: nct_alias