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Clinical Research Program

Clinical Research Program. 2003 – 2004 Melissa Adde. Major Functions. Coordination of Strategy Groups Management of Clinical Research Studies Administration of INCTR Ethical Review Committee Provision of Data Management Services Education and Training. Strategy Groups.

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Clinical Research Program

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  1. Clinical Research Program 2003 – 2004 Melissa Adde INCTR 2004

  2. Major Functions • Coordination of Strategy Groups • Management of Clinical Research Studies • Administration of INCTR Ethical Review Committee • Provision of Data Management Services • Education and Training INCTR 2004

  3. Strategy Groups • Comprised of investigators from developing countries • Disease-specific • Determine role of the group/INCTR in the control of a specific cancer • Promote public and professional education INCTR 2004

  4. Strategy Groups • African Burkitt’s Lymphoma • Breast Cancer • Cervical Cancer • Leukemia • Leukemia Study Group of India • Lymphoma • Osteosarcoma • Retinoblastoma INCTR 2004

  5. Strategy Groups Breast Cancer Retinoblastoma Leukemia (India) INCTR 2004 Keukenhof Lymphoma (African BL)

  6. Strategy Group Meetings • African BL, Aug 2004 (Tanzania) • Breast Cancer • October, 2003 (Egypt) • May, 2004 (Brussels) • Cervical Cancer, Aug 2004 (Brussels) • Leukemia/Leukemia Study Group of India • Feb, 2004 (India) • July, 2004 (videoconference) • Lymphoma, Oct 2003 (Egypt) • Retinoblastoma, April, 2004 (Brussels) INCTR 2004

  7. Translation in Actions • 5 On-going Projects (not including palliative care, IARC project, Lilly study) • 8 Projects – proposed or in development • Remember • More than simply “willingness” to collaborate • Commitment to work together to develop projects • Takes time – Rome wasn’t built in a day! INCTR 2004

  8. Strategy Groups • On-going activities will be presented and followed by discussion in Session 8 • Specific presentations will be given for: • African Burkitt’s Lymphoma (M. Durosinmi) • Breast Cancer (Z. Aziz) • Cervical Cancer (C. Santos) • Leukemia Study Group of India (S. Advani) • Retinoblastoma (S. Epelman) INCTR 2004

  9. The Treatment and Characterization of Burkitt’s Lymphoma (BL) in Africa • Primary Objectives • Characterize presentation features • Assess response, EFS, DFS and OS • Characterize pattern of CNS disease and relapse • Assess toxicities • Secondary Objectives • Characterize pattern of gene expression • Assess serum EBV DNA levels INCTR 2004

  10. The Treatment and Characterization of BL in Africa • First-Line Treatment • Newly diagnosed, previously untreated patients • Two treatment arms • Low risk arm (single extra abdominal mass < 10 cm) • High risk arm (all other patients) • Second-Line Treatment • Failures of First-Line Treatment INCTR 2004

  11. The Treatment and Characterization of BL in Africa • 5 participating institutions in 4 countries • Kenya, Nigeria (2), Tanzania, Uganda • INCTR ERC approval July, 2003 • Local ethical approval in 4 of 5 participating institutions • Patient accrual began in August, 2004 • Enrolled: 3 • Not entered: 1 (not eligible – history prior chemo) INCTR 2004

  12. Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome • Objectives • Quantify total number of breast cancer patients evaluated • Define history and presentation features of breast cancer • Define frequency of risk factors for treatment outcome (diagnosis, stage, treatment) INCTR 2004

  13. Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome • Objectives (continued) • Estimate the response, DFS and OS • Assess frequency of risk factors known to be relevant in western populations • Correlate risk factors for treatment outcome with response, DFS and OS INCTR 2004

  14. Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome • Participating institutions in 9 countries • Latin America – Argentina, Mexico and Peru • Africa – Tanzania • Middle East – Egypt, Kuwait • South Asia – Pakistan, India and Nepal • Initiate in 4 centers, then expand to others INCTR 2004

  15. Retrospective Survey of Presentation Features of Breast Cancer and Risk Factors for Treatment Outcome • INCTR ERC approval July, 2003 • Local approval in 8 of 9 participating institutions • Initiated in June, 2004 • Cancer Institute, Chennai, India INCTR 2004

  16. Phase II Study of Previously Untreated Metastatic Osteosarcoma with a Combination of Chemotherapy and Surgery • Short duration protocol (25 weeks) • Alternating cycles of 2 chemotherapy regimens every 3 weeks • Neoadjuvant and Adjuvant • Surgical resection of primary, Week 12 • Surgical resection of metastatic disease, Week 17 INCTR 2004

  17. Phase II Study of Previously Untreated Metastatic Osteosarcoma • Problem: Rate of accrual lower than anticipated rate • Observed vs “assumed” rate of accrual • PI leaving participating institution • Surgeons declined to participate • Inability to perform limb-sparing procedures • Competing group/institutional protocols INCTR 2004

  18. Phase II Study of Previously Untreated Metastatic Osteosarcoma INCTR 2004

  19. Phase II Study of Previously Untreated Metastatic Osteosarcoma INCTR 2004

  20. The Treatment and Characterization of ALL in Children, Adolescents and Young Adults • Primary Objectives • Characterize pattern of ALL in India (immunophenotype, DNA index, molecular profiling) • Correlate lab characteristics with clinical characteristics • Attempt to identify prognostic factors predictive of relapse, EFS, DFS and OS INCTR 2004

  21. The Treatment and Characterization of ALL • Secondary Objectives • To assess acute toxicity of planned therapy • To collect baseline and post-treatment assessments of neuropsychological function for future studies of late CNS toxicity INCTR 2004

  22. The Treatment and Characterization of ALL • Protocol approved by INCTR ERC, January, 2003 • Protocol approved by ICMR, May, 2004 • Protocol approved locally in 3 of 4 participating institutions • Implementation Meeting, July, 2004 • Patient accrual began Aug 1, 2004 INCTR 2004

  23. The Treatment and Characterization of ALL • Total Number of Patients Entered: 13 • Males/Females: 10/3 • Age Range: 1 – 22 years • Total Number Not Enrolled: 1 (ineligible, prior treatment) INCTR 2004

  24. Understanding Problems Faced by Parents of Children with Retinoblastoma (RB) Prior to Treatment • Objectives • To determine association between stage and time interval between first symptom, date of diagnosis and date of first treatment • To identify factors influencing time interval • To determine association between child’s age and stage • To determine if factors arise from parents, demographics or other aspects of primary health care. INCTR 2004

  25. Understanding Problems Faced by Parents of Children with RB Prior to Treatment • Participating Institutions: 15 • Contributing Institutions: 10 • India (3) • Turkey (2) • Brazil (1) • Mexico (1) • Nigeria (1) • Pakistan (1) • Zimbabwe (1) INCTR 2004

  26. Understanding Problems Faced by Parents of Children with RB Prior to Treatment • Initiated in 2001 • Experience with survey gained • Positively received by parents/guardians of children • Questionnaire and Clinical Data Form recently modified • 289 surveys recently analyzed INCTR 2004

  27. Understanding Problems Faced by Parents of Children with RB Prior to Treatment • Important Findings to Date • Older children have higher stages of disease • Strong association of higher stages in children from rural communities • Strong association of stage with father’s education level • Time interval between first symptom and diagnosis was associated with father’s education level INCTR 2004

  28. Projects in Development - 1 • African Burkitt’s Lymphoma • Treatment of Lymphomatous Meningitis with Liposomal ARAC • Phase I/II Study of Prozac in Relapse Patients • Breast Cancer • Randomized Trial Comparing Three Treatment Approaches for Stage III Breast Cancer INCTR 2004

  29. Projects in Development - 2 • Cervical Cancer • Treatment of Early Stage Cervical Cancer • Treatment of Locally Advanced Cervical Cancer • Expanding Coverage of Screening Programs INCTR 2004

  30. Projects in Development - 3 • Lymphoma • Randomized trial to evaluate the use of CHOP vs CHOP + anti-CD20 in newly diagnosed patients with Diffuse Large B Cell Lymphoma • Retinoblastoma • Treatment of Extraocular Retinoblastoma INCTR 2004

  31. Data Management of Research Studies • Design and Development of Study-Specific Databases • Retinoblastoma Survey Study • African BL Protocol • Leukemia Protocol • Approaches Used • INCTR or participating institutions perform data entry • Stand alone applications vs internet based INCTR 2004

  32. Data Quality Assurance Plans • Study-specific SOPs • data entry, queries, updates, manuals • Functions Incorporated into Databases • CRF tracking (submitted, overdue, “cleaned”) • Basic “business” rules to minimize entry errors • Minimum checks (missing or out of range values) • Extensive checks (internal consistency of data) • Listings • Query generation and tracking • Audit trails INCTR 2004

  33. Data Management • Study Specific Monitoring Plans • Data monitors appointed for certain studies • Independent pathology reviews • Periodic visits to sites for auditing purposes (using INCTR personnel or expert volunteers) • Creation of study committees (local investigators) • Assignment of responsibilities of study committees INCTR 2004

  34. Provision of Data Management Services • Within scope of INCTR mission • Relates to an important cancer in developing countries • Patient accrual completed (516 patients) Phase III randomized comparison of Gemcitabine, Cisplatin and Radiation followed by Adjuvant Gemcitabine and Cisplatin vs Concurrent Cisplatin and Radiation in Cancer of the Cervix (Stages IIB to IVA) INCTR 2004

  35. Education and Training • Protocol Implementation Meetings • Leukemia Study – July, 2004 • African BL Study – August, 2004 • Clinical Trials Workshop, Brazil, Sept, 2004 • “Basic Data Management” Workshop • Data Managers/Monitor Training for Leukemia Study (November, 2004) • In-depth review of protocol, CRFs, study procedures with practical experience (e.g., toxicity grading) INCTR 2004

  36. Special Thank You • Dr David Venzon, Biostatistician,NCI • Mr Paul Jarosinski, Pharmacist, NIH • Martha Flores-Rojo, Instituto Nacional de Pediatria, Mexico • INCTR Ethical Review Committee • Panel of External Scientific Reviewers • Capitol Technology Information Services (CTIS) • Staff of Clinical Trials Office INCTR 2004

  37. Thank You! INCTR 2004

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