Drug Development and Assessment | The Essential Role of the NCI
statistics tell us that the treatments we have are not good enough.
We continue to lose those we love. We continue to suffer
through painful and toxic therapies. And our society suffers
as patients with lymphoma become less productive and less able to
earn a living and make contributions to their communities.
Concerning current treatments for lymphoma, we
believe that the gap between what is and what's possible has never
been wider. So we dedicate this page to listing the abundant
opportunities for success, and to remind all of the urgent need to
There is an urgent need to develop and clinically test new
have greater specificity, more
potency, and less toxicity;
can overcome bulky disease;
can selectively kill indolent lymphoma cells,
that are not in cell cycle;
and enhance active immunity - the
way we naturally fight disease;
targeted therapies that may complement each other in order to
minimize toxicity and prevent tumor escape;
are rationally selected
to match the differences in the disease by using genetic
and metabolic profiling;
(please review information about the National Biospecimen
Network an innovative blueprint for progress)
thus allowing patients with
indolent lymphomas to safely receive
treatment early and more regularly;
be safely combined with existing treatments in order to cure indolent
lymphomas, and more patients with aggressive disease.
address the role of the microenvironment:
(1) Altering the host environment in ways that silence or
inhibit pro-survival signals concurrent with standard therapies.
(2) Focusing, and expanding immune surveillance against tumors.
off signals and inhibiting cells that contribute to drug resistance,
depressed immunity and escape from immunity. (4) Targeting tumors
in ways that minimize damage to immunity, or enhance it.
(5) Sequencing therapies in ways that restore positive elements of the
microenvironment in order to consolidate the response to treatments.
Development and Assessment:
- Ensure that there are sufficient incentives for pharmaceutical
companies to take the financial risks to
develop and test therapies for cancer.
- Consider reducing incentives to
develop "me-too" drugs for conditions that
are not life-threatening.
- Ensure that the FDA considers factors
such as lower toxicity and improvements in the quality of life benefits in the
assessment of new therapies.
- Encourage drug sponsors to
properly account for and measure toxicities and quality of
- Increase patient participation in clinical
trials - an essential ingredient:
- Encourage drug sponsor to
consult with informed patients and treating
to help design clinical studies that are in harmony with patients survival goals.
- Educate the communities' doctors and patients
about what studies are
available, and which show promise for specific treatment
- Encourage treating physicians to
discuss all appropriate therapies, including investigational therapies,
during treatment consults.
- Ensure that tests associated with clinical trials
are covered by government and / or insurance.
- Provide, when possible,
predictive tests to determine who is more likely to benefit
investigational therapy and/or a standard therapy used as a
pretreatment in studies.
- For example, include tests for polymorphisms in studies that utilize
- Encourage drug sponsors to test
investigational bio- and immune-based therapies earlier in the course
of the disease, when they are more likely to
provide benefit -
especially for indolent lymphomas.
- Ensure that watch & wait should not be
routine. Periods of stable
disease provide an important
opportunity to test immune-based therapies and other more targeted therapies with
safer toxicity profiles.
We must encourage drug sponsors, patients, and treating physicians
to use this opportunity:
- Better immune competence
- Less tumor burden
- Less exposure to toxic treatments
- Potential to improve quality of life
- Potential to learn without precluding the use of standard treatments
The Essential Role of the National
Cancer Institute (NCI):
- Ensure that funding of cancer research becomes a
- Encourage all cancer groups to work
cooperatively in this effort.
- Encourage the NCI to carry out its promise to
conduct translational research in order to validate
and clinically test promising new therapeutics.
- Ensure that gene-profiling technologies are fully
funded and applied as quickly as possible.
the following rationale:
- Consider providing financial incentives to managers that bring new
therapeutics to cancer patients,
and to scientist who make key discoveries to make this possible.
- Encourage clinical studies of the
many promising therapeutics and adjuvants that are not of
commercial interest, such as:
- Combinations and sequences of agents that may
complement one another.
- Immune-based strategies that have low
toxicity on patients with indolent lymphomas.
- Natural compounds that have
potential in combination with chemotherapies, such as fish oil
- Last, but NOT least: Design compassionate use protocols in advance
- anticipating the
needs of patients who fail standard therapies, and are ineligible for
clinical trials - so we can give patients every reasonable chance
to survive, and also test new concepts
in a timely manner.