The Treatment Referral
Center and Non-Research (Compassionate) use of Investigational Agents
Treatment Referral Center:
The Treatment Referral Center (TRC) is a means for the NCI to provide information to
community oncologists and other health care professionals about therapeutic options for
cancer patients. The TRC uses several resources (Physicians Data Query (PDQ),
CTEP-Information System (CTEP-IS), to maintain a referral list of the most current active
research protocols. First priority will be given to referring patients to Cooperative
Group or Cancer Center trials. If a patient is unable to participate on a clinical trial
then a non-research mechanism might be considered. Health care professionals may contact
the Treatment Referral Center regarding therapeutic options, either clinical trials or
non-research programs, by phone or fax
Phone: (301) 496-5725
Fax: (301) 402-4870.
Non-Protocol Access to Experimental Agents (MS Word)
Non Research (compassionate) release:
The three mechanisms for providing an agent on for non-research use are: Special Exception, Group C
and Treatment Referral Center Protocols. These
mechanisms differ in purpose and in reporting and procedural responsibilities of the
investigator. The ultimate purpose of the non-research (compassionate) program is to make
non-approved agents, that have significant activity against specific malignancies,
available to cancer patients and investigators. Investigators must consider the following
questions when requesting an agent for non-research use:
- Is the patient ineligible for a research protocol?
- Have standard therapies been exhausted?
- Is there objective evidence that the investigational agent is active in the disease for
which the request is being made? CTEP usually requires published phase II data as
objective evidence.
- Is the drug likely to benefit the patient?
Request for non-research use may be considered if the answer to all these questions are
affirmative.
Special Exception:
The Special Exception mechanism is the functional equivalent of an emergency IND but
differs from it in that any registered investigator may obtain an agent directly from
CTEP, instead of having to obtain an IND from the FDA. The following information is
required to consider a Special Exception request; patient identifier (name or ID #), age,
sex, diagnosis, previous cancer therapy, current clinical status, intended dose and
schedule of the requested agent (this should be based on the current literature),
potential concomitant therapy, and pertinent laboratory data. Each request is reviewed and
approved on a case by case basis.
Group C/Treatment IND:
Investigational agents that have been given Group C/Treatment IND designation by the
FDA have reproducible efficacy in one or more specific tumor types. Such an agent is
likely to alter the pattern of treatment of the disease and can be safely administered by
properly trained physicians without specialized supportive care facilities. If a drug
meets these criteria CTEP may initiate a formal application to the FDA to authorize Group
C distribution for a specific indication. Such approval is not equivalent to formal FDA
approval of effectiveness for this indication. Any registered investigator may receive a
Group C agent.
Current Group C agents:
Treatment Referral
Center (TRC) Protocols:
The NCI may make investigational treatments available via a TRC
protocol for certain high priority agents or diseases. These protocols are offered to the
NCI designated Clinical and Comprehensive Cancer Centers. All patients enrolled on a TRC
protocol must receive their investigational therapy at an NCI designated Cancer Center.
Current TRC protocols:
Agent |
Indication |
Compound 506U78 |
Relapsed or Refractory T-Cell
ALL or
T-Cell Lymphoblastic Lymphoma |
|
