Collecting Solid Tumor Tissue to Identify New Treatments



Status:Completed
Conditions:Skin Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:1/10/2019
Start Date:July 19, 2012

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Prospective Procurement of Solid Tumor Tissue to Identify Novel Therapeutic Targets

Background:

The NCI Surgery Branch has developed experimental therapies that involve taking white blood
cells from patients' tumor or from their blood, growing them in the laboratory in large
numbers, and then giving the cells back to the patient.

Objective:

This study will allow tissue samples obtained during the protocol screening process to be
used for future and ongoing research in the NCI Surgery Branch

Eligibility:

Patients must meet the minimum eligibility criteria for an NCI surgery Branch Treatment
Protocol

Design

Patients will undergo testing and evaluations as required by the appropriate NCI Surgery
Branch Treatment protocol

BACKGROUND:

- Recent advances and insights into the molecular pathogenesis of cancer have led to the
development of novel molecular and biologic targeted therapies for the treatment of
advanced cancer patients. A critical challenge in extending these studies involves the
identification and validation of new therapeutic targets for future cancer therapies.

- The Surgery Branch, NCI has an interest in identifying novel molecular and biologic
targets to facilitate the development of future cancer therapies. In addition, we have
the primary responsibility for providing surgical consultative services to the NIH. As
such, we are uniquely positioned to acquire and perform important studies on solid tumor
tissue to help identify therapeutic targets that may have significant clinical
ramifications.

OBJECTIVES:

- Primary Objective: To collect biologic samples from patients undergoing diagnostic or
therapeutic interventions for premalignant, primary or metastatic solid tumors for the
purpose of identifying novel molecular and biologic therapeutic targets

ELIGIBILITY:

- Patients greater than or equal to 18 years of age with radiographic evidence of,
biochemical evidence of, or histologically/cytologically proven solid neoplasms who
require diagnostic or therapeutic intervention as a part of the diagnosis and /or
standard of care treatment and/or follow up for their neoplasm

- Patients must have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to planned intervention

DESIGN:

- A tissue acquisition trial in which tissues will be obtained at the time of intervention

- Tissue and blood will be processed at the time of collection, stored and then
transferred to Dr. Kammula s laboratory for further processing.

- No investigational therapy will be given.

- It is anticipated that 1000 patients will be enrolled over a period of 10 years

- INCLUSION CRITERIA:

- Patients must be greater than or equal to 18 years of age.

- Patients who have a premalignant, primary or metastatic solid tumors based upon either
radiographic or biochemical testing, or histological/cytological analysis that
requires surgery or biopsy as a part of the standard of care diagnosis, treatment
and/or follow up

- Patients must have laboratory and physical examination parameters within acceptable
limits by standard of practice guidelines prior to biopsy or surgery.

- Patients must be planning to undergo surgery or biopsy as part of their treatment
plan. Note: Patients will not be enrolled exclusively for the procurement of tissue
samples.

- Patients who agree to undergo leukapheresis must meet the following criteria:

- Seronegative for HIV

- Seronegative for hepatitis B surface antigen and seronegative for

antibody to hepatitis C.

- CBC within normal limits
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 866-820-4505
?
mi
from
Bethesda, MD
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