Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer

PRIMARY OBJECTIVES:

I. Overall (composite) response rate (ORR).

SECONDARY OBJECTIVES:

I. 4-month progression free survival (PFS). II. Mutation rate. III. Adverse event
rate/severity. IV. Overall survival.

TERTIARY OBJECTIVES:

I. Targeted agent rate. II. Available protocol rate. III. Protocol enrollment rate. IV.
Disease site influence.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients undergo collection of tissue and blood samples for analysis via next
generation sequencing. Patients receive standard of care therapy based on the discretion of
the treating physician.

ARM B: Patients undergo collection of tissue and blood samples for analysis via next
generation sequencing. Based on the results of the next generation sequencing, patients
receive target-directed therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed cancer

- Patients must have evaluable disease; measureable disease is not required; however,
if measurable disease is present, it is defined as at least one lesion that can be
accurately measured in at least one dimension in accordance with Response Evaluation
Criteria in Solid Tumors (RECIST) criteria version (v.) 1.1; furthermore, if only
evaluable disease is present, a relevant tumor marker (per investigator discretion)
must be >= 2 times upper limit of normal (ULN) at baseline, and can be used as a
response indicator

- Patients must be considered good candidates for a phase 1 trial and the treating
physician must intend to enroll the patient on a phase 1 clinical protocol, if
possible; patients are not required to have progressed on their last line of therapy
prior to enrollment

- Other clinical trials are also acceptable; for example, an applicable phase 2 or
phase 3 trial may exist for which the patient would be eligible and for which
available information (inclusive of next generation sequencing [NGS]) would be
relevant to such enrollment; regardless, the pertinent point is that it is the
intent of the physician to use NGS data, to the degree possible, to select
appropriate therapy, when selecting patients for this trial

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Absolute neutrophil count > 1,000/mcL

- Platelets > 80,000/mcL

- Total bilirubin =< 1.5 times ULN and stable X 1 month

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic
oxaloacetic transaminase [SGOT]/serum glutamate pyruvate transaminase [SGPT]) < 3
times ULN (if liver metastasis is present then =< 5 X ULN)

- Serum creatinine =< 1.5 X ULN and stable X 1 month OR creatinine clearance >= 60
Ml/min/1.73 m^2

- Estimated life expectancy of >= 3 months

- Ability to understand and willingness to sign a written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

- Patients with more than one type of active malignancy; an active malignancy is
defined as one that is being treated with therapeutic intent and for which survival
may be impacted, within 3 years of enrollment

- Patients with known active brain metastases; patients with a history of treated brain
metastasis are eligible if the patient is off systemic steroids and there are no
clinical indications of central nervous system (CNS) progression for a least 1 month;
patients with glioblastoma multiforme are eligible if the above criteria are
otherwise met; note: many clinical trials do not allow enrollment of such patients;
if the physician, in good conscience, feels that applicable protocols for their
patient do exist, enrollment onto this trial is acceptable, assuming other
eligibility criteria are met

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Known human immunodeficiency virus (HIV)-positive patients on combination
antiretroviral therapy

- Pregnancy or breastfeeding