Report 2010 Clinical Research Program

The overall goal of the Clinical Research Program is the improvement of survival of patients with cancer in LMIC. It is managed by the INCTR Clinical Trials Office (CTO) in Brussels and is responsible for the management of disease-specific strategy groups that lead to development of relevant clinical research studies. The CTO assists the strategy groups to develop protocol documents, to develop data management systems and procedures for the studies and provides monitoring for data quality assurance and protocol adherence, particularly for treatment studies. The Clinical Research program works closely with INCTR's Ethical Review Committee to ensure that all clinical studies undergo ethical review prior to implementation at study sites in LMIC.

Activities and Accomplishments

  • African Burkitt Lymphoma Strategy Group

The African Burkitt Lymphoma (BL) Strategy Group is comprised of investigators from 6 institutions in four sub-Saharan African countries. The group is conducting a protocol entitled, "The Treatment and Characterization of BL in Africa". The study has been on-going since 2004 at the Obafemi Awolowu University Teaching Hospitals Complex (OAUTHC) in Ile-Ife, Nigeria, the University College Hospital (UCH) in Ibadan, Nigeria, the Kenyatta National Hospital (KNH) in Nairobi, Kenya and the Ocean Road Cancer Institute (ORCI) in Dar es Salaam, Tanzania. In 2010, St Mary's Hospital Lacor in Gulu, Uganda began enrolling patients onto the protocol. At the end of 2010, a total of 454 eligible patients have been enrolled on the protocol. Discussions were held at three new institutions - another in Tanzania, one in Senegal and another in the Democratic Republic of Congo. It is hoped that these centers will join the study in 2011.

The results of the study are promising - the overall survival (OS) for all patients entered on the protocol through the end of December, 2009 is 61'7'0 at 24 months. There are differences in OS among the institutions with ORCI and KNH having better survival rates at 2 years than the two Nigerian centers. The differences in survival may be related to the fact that families bear the burden of all aspects of care in Nigeria when compared to families in Kenya and Tanzania. This survival analysis does not include the data for the Ugandan patients enrolled since the spring of 2010 as it is still too early to include them in such an analysis. It is also encouraging that the second-line treatment has resulted in the cure of many patients in the setting of early relapse or partial response to the first line treatment regimen. A manuscript of the results from the initial four centers is being prepared.

The group collaborates closely with the Pathology Program. The use of iPath has been introduced at several sites such that there can be on-line consultation and the majority of cases have been reviewed by the members of the Pathology Program for confirmation of diagnosis.

In April 2010, a new database system was implemented such that the site data managers can enter data "off-line" and upload entered data to the central server by performing a simple "synchronization" procedure that requires minimal internet connection time. By storing data on the central server, system upgrades are transparent to the users and the data is stored securely and virus-protected.

In January 2010, monitoring visits of the two sites in Nigeria - OAUTHC and UCH took place and in November 2010, monitoring visits of St Mary's Hospital Lacor and ORCI.

  • Leukemia Study Group of India

The Leukemia Study Group of India is comprised of investigators representing four institutions - the All India Institute of Medical Sciences (AIIMS) in Delhi, the Cancer Institute (CI), Chennai, the Tata Memorial Hospital (TMH) in Mumbai and the Jaslok Hospital in Mumbai. In 2004, a protocol entitled, "The Treatment and Characterization of Acute Lymphoblastic Leukemia (ALL) in Children, Adolescents and Young Adults" was implemented. A total of 473 patients were enrolled on the study, but due to protocol violations and incomplete data from one center, only the data for 387 patients from AIIMS, CI and TMH has been analyzed. Of those 387 patients, 92'7'0 achieved a complete response. Patients enrolled at CI were older, had more T cell disease, were of lower socioeconomic status and were from rural regions than the other two centers. For all patients, OS is 66'7'0 at 3 years. When comparing the centers, TMH had a better OS than the other two institutions and also had a significantly lower rate of relapse. Approximately 77'7'0 of patients who died during remission of toxicity were of lower socioeconomic status. This raised the question that when such patients are at home, access to care for febrile neutropenia or other acute problems may be a major factor that has contributed to their deaths. The results should be considered preliminary as patients enrolled in late 2009 have not yet completed treatment and it must be kept in mind that very few patients with T cell ALL were enrolled at TMH.

  • Retinoblastoma Strategy Group

Members of the Retinoblastoma Strategy Group are assisting with efforts to improve the earlier detection of this curable cancer in sub-Saharan African countries by providing materials utilized in campaigns to increase public awareness and by supporting initiatives led by other INCTR branches, such as AMCC in these countries. In Tanzania, emphasis is being given to educating health care professionals about this disease.

  • Nasopharyngeal Cancer (NPC) Strategy Group

A questionnaire study was designed and piloted by investigators treating both pediatric and adult patients with NPC in 2009. The protocol entitled, "A Descriptive Study of NPC in LMIC: Part I, Determinants of Delays in Diagnosis and Treatment in NPC and Part II, Consanguinity and Familial History was approved by INCTR's ERC in March 2010. Of the 17 institutions that agreed to participate in this study, 7 institutions have obtained local ethical approval and submission of questionnaires began in late 2010.

  • Wilms' Tumor Strategy Group

Members of the Wilms Tumor Strategy Group, led by Dr. Sameer Bakhshi of AIIMS, have drafted a protocol entitled, "The Treatment of Wilms Tumor in LMIC". The objectives of the study are to characterize the clinical and pathologic features of this disease in different LMIC and to assess EFS and OS of a uniform treatment protocol. The treatment utilizes an approach similar to that used in SIOP studies - with pre-operative chemotherapy to decrease the size of the tumor, since the majority of children in developing countries present with very large tumors which in turn, makes up-front surgery more difficult and subject to tumor spillage, which has adverse effects on the overall prognosis. It is anticipated that the protocol will be completed in 2011 and undergo ethical review.

  • Clinical Trials Education and Training

The CTO continues to provide support as needed to the efforts of INCTR Brazil in their on¬going clinical trials accreditation program.

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