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Protocol Details

Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

06-C-0213

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 mo
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Adults who are or may become unable to consent

Special Instructions

Currently Not Provided

Keywords

Tissue Collection;
Biospecimen;
Assay Development;
Tissue Acquisition;
Tissue Biopsies;
Natural History

Recruitment Keyword(s)

Tissue Collection

Condition(s)

Neoplasms;
Lymphomas;
Multiple Myeloma;
Myelodysplastic Syndrome

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

-Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.

Objectives:

-To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.

-To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.

Eligibility:

-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center and adult patients from participating sites.

Design:

-This is a multicenter tissue procurement protocol with NCI as the coordinating center.

-For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.

-For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.

-Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.

-This study has three separate consent forms: one for adult patients at the NIH Clinical Center to opt to donate their samples for ongoing research on assay development and studies of molecular pathways; and two for the generation of preclinical models (adult and pediatric). Adult patients at the NIH and participating sites, and also pediatric patients (NIH Clinical Center only), can opt to donate samples to create preclinical models to study tumor biology and genetics, and to develop new therapies for cancer.

-Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.

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Eligibility

INCLUSION CRITERIA - ADULT:

-Patients 18 years of age and older who are being evaluated and/or treated for cancer at the NIH Clinical Center or at participating sites:

--Who have a newly diagnosed solid tumor, lymphoma or multiple myeloma malignancy for which they have not yet received treatment, or

--Who have a previously treated solid tumor, lymphoma or multiple myeloma malignancy that is now recurrent or currently progressing on treatment indicated by:

---Radiographic evidence of tumor growth and/or new metastases, or

---documented evidence by the treating physician of signs/symptoms of clinical disease progression, or

--Who are currently undergoing treatment (adjuvant, neoadjuvant, etc.), are within the first two (2) cycles of treatment, and for whom disease response has not yet been assessed

---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.

--Patients with ongoing partial response (PR) or stable disease (SD) are eligible.

---Confirmation of viable malignancy and/or <90% tumor necrosis must be confirmed to the coordinating site, as indicated in the final pathology report, for patients enrolled with PR or SD.

-Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol.

-At the NIH Clinical Center ONLY:

--At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and/or treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Nonpolyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer

(HDGC) syndrome.

--Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and/or treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and/or MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.

EXCLUSION CRITERIA - ADULT:

-Patients with invasive fungal infections

-Patients with active and/or uncontrolled infections or who are still recovering from an infection:

--Actively febrile patients with uncertain etiology of febrile episode

--All antibiotics should be completed at least 1 week (7 days) prior to collection

--No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics

--Note: Use of antibiotics for pre-operative prophylaxis is not an exclusion.

-Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

-Patients with Hepatitis A as indicated by anti-HAV IgM reactivity

--Note: Patients that are anti-HAV IgG reactive only are not excluded

-Blood only collections from patients with partial or stable disease response:

--Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such specimens.

--Blood will not be collected from patients between doses within a single treatmentcycle.

-Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.

INCLUSION CRITERIA - PEDIATRIC:

-Patients younger than 18 years of age with a histologically or cytologically confirmed diagnosis of cancer (solid tumor, lymphoma or multiple myeloma) who are being treated for cancer at the NIH Clinical Center and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue collected. Tissue from neonates will not be collected.

-At the PIs discretion, collections may occur from patients with pediatric tumors that 14 are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.

-Ability and willingness to assent to participation, utilizing an explanation that is understandable/age appropriate, as well as receiving parental permission.

EXCLUSION CRITERIA - PEDIATRIC:

-Patients with invasive fungal infections

-Patients with active and/or uncontrolled infections or who are still recovering from an infection:

--Actively febrile patients with uncertain etiology of febrile episode

--All antibiotics should be completed at least 1 week (7 days) prior to collection

--No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics

--Note: Use of antibiotics for pre-operative prophylaxis is not an exclusion.

-Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

-Patients with Hepatitis A as indicated by anti-HAV IgM reactivity

--Note: Patients that are anti-HAV IgG reactive only are not excluded

-Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR) based on imaging.

-Blood only collections from patients with partial or stable disease response:

--Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing (i.e., prolonged) stable disease given the poor rate of model generation from such samples.

--Blood will not be collected from patients between doses within a single treatment cycle.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

James H. Doroshow, M.D.
National Cancer Institute (NCI)
BG 31 RM 3A44
31 CENTER DR
BETHESDA MD 20814
(240) 781-3320
doroshoj@mail.nih.gov

Nancy Moore, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6045
nancy.moore@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT00900198

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