Sample Collection and Tracking for the Developmental Therapeutics Clinic

Background:

Research samples and data collected on a treatment-intent protocol are discrete items
associated with that protocol up until the patient comes off study, usually due to disease
progression. These data are not stored in the patient s medical records, but are essential to
understand tumor response to different drugs over time. Patients in the Developmental
Therapeutics Clinic (DTC) often start other clinical trials; this protocol provides a
mechanism to connect research data about that patient from one trial to the next as long as
the patient remains eligible and has given his or her informed consent. No new analysis will
be performed under this protocol. There is research interest in collecting pre- and post-dose
research biopsies and other samples such as circulating tumor cells to measure dynamic
drug-specific target effects (e.g., changes in epithelial-mesenchymal transition, DNA damage
response, or immunotherapeutic cell infiltration), and then to evaluate molecular changes
before and during disease progression to understand why the tumors initially respond but then
became resistant to treatment. To accomplish this, we will connect research results from
consecutive trials with limited patient information (age, gender, disease, prior therapies,
protocol number/drug regimen, response, and duration of treatment). Each patient who consents
to participate in this non-treatment, longitudinal sample protocol agrees to allow his or her
Medical Record Number (MRN) to be used to track participation on DTC clinical trials.

Objectives:

Patients will be entered onto this "master" longitudinal protocol to connect research sample
and treatment data across consecutive DTC clinical trials. Biopsy samples collected at time
of disease progression on one research trial will be evaluated for use as the baseline sample
for the next research trial, potentially obviating the need for additional biopsies.

Eligibility:

Adult patients who are being evaluated for and/or treated for cancer at the DTC.

Design:

No samples will be collected under this longitudinal protocol, no treatment decisions will be
made based on data collected, and no new analysis will be performed. Specimens for research
purposes, as outlined in this protocol, will be those obtained from tests and procedures that
are done as required by the primary research protocols that a given patient is enrolled in.
Tissue collected under DTC tissue procurement protocol 06-C-0213 will not be used or tracked.
Sample location and use will be managed in the Repository at the Frederick National
Laboratory for Cancer Research using LabMatrix software. Patients may remain on this
longitudinal protocol for the duration of their consent.

- INCLUSION CRITERIA:

- Patients who are being evaluated and/or treated for cancer in the Developmental
Therapeutics Clinic at the NIH Clinical Center

- Ability to understand and willingness to sign a written informed consent document
indicating their willingness to have data from their tissue or biologic fluid research
specimens and limited medial information used for research as outlined in this
protocol and to allow protocol staff access to the CRIS database and their Medical
Records Number (MRN).

- Age greater than or equal to 18 years

ECLUSION CRITERIA: