Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00026663 |
| Other study ID # |
000078 |
| Secondary ID |
00-C-0078 |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 9, 2000 |
Study information
| Verified date |
June 5, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
Deneise Francis, R.N. |
| Phone |
(240) 858-3974 |
| Email |
deneise.francis[@]nih.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
Other known NCT identifiers
