IBTA
E News January 2012
Dear Friend
Click here to return to the main webpage for the IBTA.Patient
resource: There is a very useful podcast explaining a CT scan to
patients that was released on 2 January by ASCO. It is available here and
lasts for 5 mins 40 secs. While intending to cover all cancers it answers most
questions asked by a patient referred for a CT scan of the brain.
Paediatric
brain tumour research: In a
recent report US Phrma
identified 53 medicines in clinical trial development or FDA review for
paediatric cancer of which 12 were specifically associated with brain tumours,
while several others were being investigated for solid tumours in general.
The name, indication
and status of the brain tumour medicines or therapies are: ARC-100 (medulloblastoma)
Phase I/II; cintredekin besodotox (glioma) Phase I; GliAtak (malignant brain tumors),
Phase I; Nexavar (glioma),
Phase II; nimotuzumab (recurrent glioma),
Phase II; PTC299 (CNS cancer) Phase 1; SL-701 (glioma)
Phase I/II; Tarceva (recurrent/refractory ependymoma) Phase II; TheraCIM
(recurrent DIPG) Phase II; vismodegib (medulloblastoma) Phase II;
Xeloda (gliomas)
Phase I; Xerecept (brain edema
associated with brain tumors) Phase I/II.
Those therapies listed above appear to be
company-initiated studies, as opposed to investigator-initiated studies. For
example, the CERN
Foundation also has an on-going paediatric study (CERN08-01) of
bevacizumab and Lapatinib
for recurrent or refractory ependymoma.
MRS
and IDH1: Scientists have used magnetic resonance spectroscopy
(MRS) to identify the
IDH1 mutation in both tumour samples and patients with glioma
brain tumours by searching for the molecule 2-hydroxyglutarate (2HG). It has
been suggested
that this may "dispense with the need for invasive surgery".
Hopefully, the results of this technique will be used to develop targeted
therapies, rather than just tracking a patient's progress.
At the present time
surgery is used not only to identify the type and grade of tumour but as a debulking process prior to use of the concomitant
therapy. Patients are likely to be
puzzled should a Doctor say: "We don't need to operate, from the MRS we
know you have a glioma with the IDH1 mutation". In a recently released US Patterns of Care
(POC) study for
2006 approximately 65% of patients with a GBM received a partial or total
resection. There might be a relevance for the MRS technique in the case of
inoperable tumours.
Drug
shortages: The USA has continued to experience shortages of drugs,
particularly sterile injectable drugs, including
those relevant to cancer treatments. It
is not known if this has had a flow-on effect in other countries. Drugs
currently on the FDA's shortage
list,
which shows individual supplier shortages and alternative sources, and which
may be relevant to brain tumour treatments, include: Cisplatin injection 1 mg/mL solution, Dexamethasone Injection, Methotrexate
Injection-Preservative Free, Midazolam Injection, Ondansetron
Injection 2 mg/mL, Vincristine
Sulfate Injection.
Commemoration
and conference days: 7 February has been designated as International
Childhood Cancer Awareness Day. Now
that CNS tumours have overtaken all leukaemias as the
greatest childhood cancer killer in many countries it represents an opportunity
to raise awareness about the need for greater support and research for
paediatric brain tumours.
Rare Disease Day
will be marked in Europe on 29 February - chosen because that date is a
"rare date". In the USA on 29
February the National Institutes of Health will also hold a Rare
Disease Day. On the following day (1 March) the FDA will
host a Rare
Disease Patient Advocacy Day. By definition all
paediatric cancers are "rare diseases". In Brussels on 10 February the European
Society for Medical Oncology (ESMO) and Rare Cancers Europe (RCE) will jointly sponsor a
conference on clinical trial methodology for rare cancers.
Trabedersen: On 11 January Antisense Pharma announced that they have decided to terminate the ongoing
Phase III trial (the Sapphire trial) for recurrent or refractory anaplastic astrocytoma (AA) or secondary glioblastoma (GBM ) due to
slow patient recruitment. The company will pursue 1st line treatment
of GBM with standard of care. We will
advise when any information about the next trial in high grade glioma
is available.
The company stated:
" Recruitment delays are a result of changes in the histopathological
grading of patients, introduced by the WHO, which considerably reduced the
number of patients diagnosed with AA, already a rare, orphan disease. In
addition, advances in the standard of care for 1st line patients have rendered
many treated patients unsuitable for inclusion, as they no longer receive
radiotherapy. Attempts by the management to identify and implement an effective
solution, such as amendments to the study design, have not yielded significant
improvements in the recruitment rate."
Recent developments and promising therapies: Two
researchers from Barcelona have discovered that
the molecule CPEB4 turns on hundreds of genes that play critical roles in the
progression of pancreatic cancer and
brain tumours. Inhibiting the process might be a useful form of targeted
therapy.
Dutch company to-BBB has received a grant of
€600,000 from a Dutch government agency to support a brain drug delivery
partnership with a (as yet unnamed) top-5 pharma
company using its G-Technology which enhances the delivery of specific
drugs to the brain. In June 2011 the Company announced approval for a Phase
I/II clinical trial testing its product
2B3-101 for brain metastases from breast cancer.
Northwest
Biotherapeutics: On 9 January the company
announced plans
to have at least 30 sites open and enrolling by the first quarter of 2012 for
its DCVax immune therapy for GBM and will pursue
programs in Europe.
On 4 January Celldex Therapeutics announced
"... that
patient screening has initiated in a Phase 2 trial of rindopepimut
in combination with Avastin in
patients with recurrent epidermal growth factor variant III (EGFRvIII)-positive glioblastoma,
called the “ReACT Study.” This new study will run in
parallel with Celldex’s Phase 3 trial (ACT IV)
evaluating rindopepimut in patients with newly
diagnosed EGFRvIII-expressing glioblastoma
(GB)."
On 5 January the
German-based company Apogenix announced
the raising of further funds to advance the Phase II clinical trial of its drug
APG101 to treat GBM. Final results of the trial are expected in the first
quarter of this year. One of the investors is the German Cancer Research
Centre.
Brain
tumours and weather forecasting: The complete novelty of a scientific paper
which seeks to apply principles of
weather forecasting to the spread of an individual's GBM was bound to attract
attention in the popular media. The open-access paper can be downloaded here. In a subsequent
interview
the principal author Eric Kostelich from the
University of Arizona revealed that he was prompted to focus on brain tumours
because he had a family member with a brain tumour.
The authors believe that "... this preliminary study demonstrates
the potential feasibility of ensemble forecasting and data assimilation methods
for short-term prediction of the growth and spread of malignant brain tumors." They warn that "considerable work
remains before our approach can be seriously considered in clinical
settings." In the interview referred to earlier Kostelich
suggests that the research (essentially based on MRIs and the behaviour of GBMs in other patients) might enable pre-emptive action to
forestall development of a GBM in a certain direction, or a forecast that
continuation of a chemotherapy might be unproductive.
In all such research the evaluative
criteria should be "will this be of benefit to the patient", rather
than simply helping the clinician to confirm the accuracy of a rather dire
prognosis.
Danish
brain tumour statistics: The 2010 report of the Danish Cancer
Registry notes an increased incidence of CNS tumours in men. In the rather
uncertain language of a Google translation it is stated: "There
was a significant increase of
tumors in the brain and central nervous system in men. The increase is 16
percent. in incidence
rate, the responses to (which
corresponds to?) an increase in the
number from 638 to
748 (between 2009 and 2010?). There is
no similar increase among women. The reason for the increase in men is uncertain. Over the
past 10-year period (we have) seen a steady increase,
which to some extent (is) a reflection of increased diagnosis as a result of
a general focus on the detection
of cancer with highly increased imaging activity."
IBTA Co-Director Kathy
Oliver will attend the Drug Information Association conference in Copenhagen in March and in April
it is hoped that IBTA officials can meet with representatives of the
Scandinavian brain tumour support and advocacy groups to discuss areas of
common interest.
2012 IBTA Brain Tumour magazine: Work has commenced on the 2012 edition of the
IBTA's Brain Tumour
magazine. The suggestions about content
made by 279 respondents to the IBTA's 2011
satisfaction survey have been carefully analysed and incorporated where
possible in the magazine planning. Two recommended subjects we would like to
cover and for which we are seeking authors are: (1) the relevance of
stereotactic radio surgery for meningiomas, and (2)
the use of boswellia in Germany for brain oedema as
an example of a useful complementary treatment.
Please contact chair@theibta.org if you know of possible contributors on
these subjects. Limited copies of the
2011 Brain Tumour magazine are still available and free copies
can be requested here.
Thank you for your continuing support. We wish all our
readers a successful New Year.
Denis Strangman(Chair
and
Co-Director)
International Brain Tumour Alliance IBTA
www.theibta.org
Kathy Oliver
(Co-Director)
PO Box 244, Tadworth, Surrey
KT20 5WQ, United Kingdom
Tel:+ (44) + (0) + 1737 813872
Fax: + (44) + (0) +1737 812712
Mob: + (44) + (0) + 777 571 2569
The International Brain Tumour Alliance is a not-for-profit, limited liability
company registered in England and Wales, registered number 6031485.
Registered office: Roxburghe House, 273-287 Regent
Street, London W1B 2AD, United Kingdom. All correspondence should be sent
to the Co-Directors address above, not to the registered office.
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