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CANCERWISE- ICORG Article Autumn 2002 , Volume 1, Issue 3

Cancerwise, Volume 1, Issue 3, Autumn 2002

ICORG holds successful lung, GI and breast research strategy meeting

The meeting took place on Saturday, 14th of September 2002 in the Marriott Druids Glen. Thirteen ICORG investigators participated and seven new study ideas were agreed by the end of the meeting.

As a result, ICORG plans to have new protocols in place for the treatment of advanced lung, early and advanced GI, oesophageal, first line metastatic breast and early HER2 negative breast in the coming months. These ideas were as a result of much discussion and input from all who attended and in the end were unanimously agreed upon.

In attendance were Dr John Armstrong, Dr John Crown, Dr Oscar Breathnach, Dr Eileen O’Reilly, Dr John McCaffrey, Dr Brian Cantwell, Dr John Kennedy, Dr Liam Grogan, Dr Kyran Bolger, Dr Paula Calvert, Dr Karen Duffy, Dr Paul Donnellan and Mr Tom Walsh.

ICORG anticipates holding a number of similar strategy meetings in other areas in the coming months.

Update on haematology.

ICORG has for many years been involved in helping bring haematology research to Ireland and also in assisting the Irish Haematology Association in setting up their ICORG studies. Recently, there have been a few notable successes including the three Glivecstudies: 113, 114 and 115 were open label multicentered phase III studies to determine the efficacy and safety of STI 571 Glivec in patients with Chronic Myeloid Leukaemia who are refractory to or intolerant of Interferon. During the study, patients received a once daily oral dose of STI571 Glivec.

I wish to acknowledge Sr Peig Carroll , the research co-ordinator, for the very high standards to which this study was run and for the graphs included in this report.

These studies met some very exacting timelines and set some very high standards in the way they were conducted and the all-Island teamwork that led to their success.

The opening of the main research site at St. James’s hospital was completed in a record number of days (only 16) with the co-operation of the Irish Medicines Board. Once open, the site had the highest rate of accrual in Europe. Enrolment for the study commenced in October 2000 and in just one year a total of 39 Irish patients were enrolled. This figure is extraordinary in that it represents over 90% of all CML cases in Ireland during the period of the study.

The exceptional patient enrolment was due to the leadership of Professor Shaun McCann of St. James’s Hospital, one of Ireland’s leading international investigators, as well as the co-operation of the members of the Irish Haematological Association. The study was conducted solely at the St. James’s site with patients referred from six of the eight regional health boards, including Northern Ireland.

Professor Shaun McCann has made it known that the success of the study would not have been possible without the co-operation and assistance of the referring consultants.

The objective of the study was to determine the efficacy and safety of a drug called Glivec (formally STI 571) in patients intolerant of/or unresponsive to Interferon alpha. Interferon alpha has been shown by large international studies to be associated with an increase in life expectancy in patients with CML, but due to side effects many patients discontinue treatment. Results of the Glivec study have shown that given continuously as a single oral daily dose, complete haematological and cytogenetic responses in chronic phase Chronic Myeloid Leukaemia have been induced, with reduced side effects.

The study also marks a major achievement for ICORG. It was the first trial set up by the group involving patients from both the Republic and Northern Ireland since the organisation became an island of Ireland entity. Indeed, the second highest number of referrals for the study came from Northern Ireland. It is without doubt that this accomplishment will lead to a growing interest internationally in Ireland as a location for leading edge haematological research.

ICORG wishes to thank the Irish affiliate of Novartis, the manufacturers of Glivec, who sponsored the study. Glivec became commercially available in Europe in November 2001 and there are currently a number of trials where the use of this treatment is being tested for a variety of different cancers. As a result of this collaboration a national database for CML is in the process of being set-up.

Important points of note

There are currently 30 trials where the use of STI571 is being tested for a variety of different cancers. These include:

* 113 Protocol for patients with chronic phase CML (26 Patients were enrolled into this protocol)
* 114 Protocol for Patients in Accelerated Phase (8 Patients were enrolled into this protocol)
* 115 Protocol for patients in Blast Crisis (4 Patients were enrolled into this protocol)

ICORG 00-03
An open label, multicentred, phase III study to determine the safety and efficacy of STI 571 in patients with CML who are haematologically or cytogenetically resistant or refractory to interferon alpha or intolerant of interferon alpha (0113).

ICORG 00-04
An expanded access protocol of STI 571 in adult patients with either CML in accelerated phase or Philadelphia chromosone-positive acute lymphoblastic leukaemia ( 0114).

ICORG 00-05
An open-label, multicentre, expanded access study of STI 571 in patients with either CML in myeloid or lymphoid blast crisis, or Philadelphia chromosone-positive acute lymphoblastic leukaemia (0115)

New haematology studies in process

To start soon

A phase III study to evaluate the efficacy and safety of front-line therapy with Alemtuzumab (CampathÒ) versus Chlorambucil in patients with progressive B-cell chronic lymphocytic leukaemia. ICORG 01-10. (Sponsored by M& I Partners, coordinated by Ilex Services Ltd.)
The objective of this study is to demonstrate that Campath is superior to Chlorambucil as front-line therapy in patients with progressive B-CLL as measured by progression-free survival.
It is an open label, multicentre, randomised comparative study, which will enrol an estimated 284 patients from 30 or more study centres in Europe and the USA. In Ireland, the participating sites are St. James’s & Adelaide and Meath Hospital, Dublin and University College Hospital, Galway, for which enrolment began in May 2002.
An open-label study of high-dose Liposomal Amphotericin B (AmBisome) in the treatment of definite and probable fungal infections. ICORG 02-02. (Supported by Gilead Sciences)
The study objective is to evaluate the response rate of a high-dose regimen of AmBisome in patients with definite and probable mould infection or chronic disseminated (hepatosplenic) candidiasis.

A total of 110 patients will be enrolled from six centres in the UK, Ireland, Sweden, Finland and the Netherlands. In Ireland, the study has recently received approval from the Irish Medicines Board and will be opening shortly at St. James’s, Dublin.

An Open-Label, Phase II Trial of Proteosome 344 in patients with Multiple Myeloma

Under review

The following studies are being reviewed by some ICORG investigators with a view to them becoming ICORG studies and with the sponsors’ agreement widely available by those interested in taking part:

(i) A multicentre, international, parallel group, controlled, randomised, double-blind, study of a thalomide analogue plus dexamethasone versus dexamethasone alone in previously treated subjects with multiple myeloma

(ii) A multi-centre, parallel group, controlled, randomised, double-blind study of Thalomide plus glucocorticoid therapy versus placebo plus glucocorticoid therapy as induction therapy for previously untreated subjects with multiple myeloma

Haematologists – important ICORG constitutional referendum in autumn

Following executive review earlier this year it has been suggested that the ICORG executive should expand and that one of the changes should be an executive position for the leader of a newly separated haematology modality. This decision will be facilitated by the recent vote by ICORG members through a constitutional referendum to make the process of constitutional change more straightforward, i.e. a change can be made by means of a simple majority of those who vote rather than two-thirds of the full membership.

The result of this referendum will be announced in the Winter edition of cancerwise as well as by direct email/letter to all members.

Brian Moulton is chief executive officer of ICORG

For more information: http://www.icorg.ie or Dr Brian Moulton, CEO, Irish Clinical Oncology Research Group, 120 Pembroke Road, Dublin 4. Phone: +353 16621590, .(JavaScript must be enabled to view this email address)