Collection of Tissue Samples for Cancer Research

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 on adult
patients at the NIH Clinical Center 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 as listed in Section 8.2; 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
specimens to create preclinical models to study tumor biology and genetics, and to
develop new therapies for cancer as described in Section 8.1.

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

- 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.

- For matched pair collections only (tissue + blood), 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.

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

- 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.

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.

- Ability to understand and willingness to sign a written informed consent document
indicating their willingness to have their tissue or blood/biological fluid samples
used for research as outlined in this protocol, or, consent from a parent/guardian
with assent from the child.

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.