
Consent
to Anonymous Online Reporting
Study candidates must have a diagnosis of cancer.
There must be no single, “best” treatment which is universally accepted for the candidate’s diagnosis and clinical situation. (There is seldom a situation in oncology where this is the case.)
The candidate must have viable tumor cells which are accessible by biopsy.
The candidate must be able to receive
chemotherapy. This means that the
candidate should be ECOG performance status 0 or 1 and has no contraindications
for receiving traditional, cytotoxic chemotherapy, chemotherapy with anti-kinase
“targeted” agents, or antiangiogenic agents.
The subject’s physician must be qualified and
willing to administer the chemotherapy regimen which is identified through
functional tumor cell profiling and to provide clinical reports.
Alternatively, the candidate must be willing to receive treatment and/or
evaluation from a participating investigator.
Consent to Anonymous Online Reporting
The candidate must agree to allow his or her
physician to provide the study investigators with data concerning treatments and
treatment results, to include extended follow-up, for analysis and online
posting. Participants’ identities
will be closely-guarded - anonymity
will be strictly enforced in all online reporting.
Coded identity numbers will be used in accordance with standard practice.
An ethical consideration which the
investigators
impose upon themselves is the determination that no financial hardship should
accrue to any patient. Patients who enter the study must be able to afford
novel treatments which might be
identified for them by comprehensive cell profiling. As a general
guideline, we strongly advise that no patient enter this
study if such involvement requires the acquisition of substantial debt, such as from loans,
mortgages, or liquidation of assets.
For patients who do not qualify from a financial standpoint, we will strive to identify the best treatment outside the context of this clinical trial, using established, commercial CytoRx and EGFRx Functional Tumor Cell Profiling services.
As
stated above, it
is certain that the largest expense to the patient will be associated with the
actual treatments – especially the drugs.
These charges will be levied by the independent hospital, oncologist, or cancer
center which administers the treatment.
The
Weisenthal Cancer Group derives absolutely no financial benefit from
recommending any specific treatment.