Clinical Research Program Report

1
Clinical Research Program Report

• INCTR Annual Meeting 2005
• Melissa Adde, Director Clinical Trials Office

2
General Description of Program

• Main Functions
• Coordination of Strategy Groups
• Management of Clinical Research Studies
• Serve as the Data Center for Clinical Research
  Studies
• Provision of Education and Training Related to
  Clinical Trials
• Other Functions
• Administration of INCTR Ethical Review Committee
• Provision of Data Management Services

3
Strategy Groups A Brief Review

• Comprised of investigators from countries with
  limited resources
• Disease-specific (African BL, Breast Cancer,
  Cervical Cancer, Leukemia, Leukemia Study Group
  of India, Lymphoma, Osteosarcoma, Retinoblastoma)
• Determine the role of INCTR in the control of a
  specific cancer
• Design of clinical research studies

4
On-going Clinical Research Studies

• Understanding Problems Faced by Parents of
  Children with Retinoblastoma Prior to Treatment
• The Treatment and Characterization of Acute
  Lymphoblastic Leukemia in Children, Adolescents
  and Young Adults
• The Treatment and Characterization of Burkitts
  Lymphoma in Africa
• A Retrospective Survey of Presentation Features
  of Breast Cancer and Risk Factors for Treatment
  Outcome

5
Retinoblastoma Study

• Survey study of parents of children with
  retinoblastoma (questionnaire)
• Objective
• To identify the factors contributing to delays in
  diagnosis and obtaining treatment

6
Retinoblastoma Study

• 11 institutions from 8 countries have contributed
  data to this study
• Brazil
• Bolivia
• Mexico
• Nigeria
• Zimbabwe
• Turkey (2 institutions)
• India (3 institutions)
• Pakistan

7
Retinoblastoma Study
Number ()
Fathers 161 47.5
Mothers 147 43.4
Guardians 30 8.8
Patient 1 0.3
Total 339 100
8
Retinoblastoma Study Summary of Findings

• Children from rural areas had higher stages of
  disease
• Older age children had higher stages of disease
• Fathers education level was associated with St
  Jude Stage of disease (the lower the education
  level, the higher the stage)
• Lower education levels of fathers were associated
  with increased time intervals between detection
  of first symptom and diagnosis

9
INCTR 02-04 - Objectives

• Characterize the pattern of ALL in India
  (immunophenotype, DNA index, molecular profiling)
• Correlate laboratory findings with clinical
  characteristics
• Identify prognostic factors predictive of relapse
  and survival

10
INCTR 02-04 Total 149 Patients
Total No ()
Gender Males 99 (66.4)
Females 50 (33.5)
Age (years) 1 - lt 2 6 (4.0)
2 9 80 (53.7)
10 17 41 (27.5)
18 25 22 (14.8)
Phenotype Precursor B 70 (64)
Precursor T 35 (32)
11
INCTR 02-04 Off-Study Patients
Deaths 16
Relapse 7
Lost to follow up 5
Toxicity 3
No response to I1 2
Voluntary withdrawal 2
Other 1
Total 36
12
INCTR 02-04 Summary

• More intensive than MCP841
• Too soon to evaluate outcome differences with
  MCP841
• Data monitoring has been introduced
• Web-based data entry has been introduced
• Study committee comprised of PIs formed which is
  actively making protocol-related decisions

13
INCTR 03-06 - Objectives

• Characterize the presentation features of African
  Burkitt Lymphoma
• Assess response and survival
• Utilizes standard treatment (CTX, VCR, MTX and IT
  therapy) for Africa
• Includes second-line treatment for NR or relapse
  patients (IFOS, ETOP, ARAC, IT therapy)
• Improve data collection and patient follow-up

14
INCTR 03-06 Patient Characteristics
Gender Males 54
Females 29
Age (years) Range 2 - 28
Median 7
Risk Group High Risk 83
Total 83
15
INCTR 03-06 Off-Study Patients
Deaths 11 (13.2)
Induction 7
Remission 1
PD 3
Lost to Follow Up 9 (10.8)
Treatment failures 5 (6.0)
Voluntary withdrawals 5 (6.0)
Total Off-Study 30 (36)
16
INCTR 03-08

• Retrospective Survey of Female Breast Cancer
  Patients 1993-2001
• Presentation features
• Treatment received
• Outcome
• Data retrieval is underway in 4 institutions
  (Peru, Egypt, India, Pakistan)

17
Studies in Development

• African Burkitt Lymphoma
• Phase II Study of Depocyte (relapsed CNS disease)
• Breast Cancer
• Randomized study comparing two neoadjuvant
  approaches in the management of locally advanced
  breast cancer
• Retinoblastoma
• Treatment of extraocular retinoblastoma

18
Reasons for Delays in Study Development

• Requires Group Consensus
• Takes time to achieve and compromise is necessary
• Requires willingness to work in a group vs
  independently
• Competing Local Issues
• Little time to devote to protocol development and
  writing
• Local priorities and projects can take precedence
  and in some cases prohibit participation
• Motivation for Conducting Research Differs

19
Education and Training in Clinical Research

• Protocol-specific Data Manager Training Courses
• Indian ALL Study (Nov 2004)
• African BL Study (Nov 2005)
• Breast Cancer Survey Study (2006)
• Introduction to Basic Data Management
• Manila Philippines June 2005
• Amman Jordan April 2006

20
Thank You

• PIs and Data Managers involved in on-going and
  completed studies
• David Venzon
• Paul Jarosinski
• OIA and NCI Liaison Office
• INCTR ERC
• Julia Challinor
• Lolita Lantican
• Corinne Claes