Author Contributions: Drs Lange and Alonzo
had full access to all of the data in the study and take responsibility for
the integrity of the data and the accuracy of the data analysis.
Study concept and design: Lange, Feusner, Skolnik,
Sacks, Smith, Alonzo.
Acquisition of data: Lange, Feusner, Sacks,
Analysis and interpretation of data: Lange,
Gerbing, Feusner, Skolnik, Smith, Alonzo.
Drafting of the manuscript: Lange, Gerbing,
Skolnik, Sacks, Smith, Alonzo.
Critical revision of the manuscript for important
intellectual content: Lange, Feusner, Skolnik, Sacks, Smith, Alonzo.
Statistical analysis: Lange, Gerbing, Skolnik,
Obtained funding: Lange.
Administrative, technical, or material support:
Lange, Feusner, Skolnik, Sacks, Smith.
Study supervision: Lange, Feusner, Smith.
Funding/Support: This study was supported by
grants CA098543 and CA098413 from the National Institutes of Health (NIH)
from 2000 to 2004 and NIH U-10 grants listed at
from 1996 to 2000. Dr Lange was supported by the Yetta Dietch Novotny
Chair in Clinical Oncology. Chiron provided interleukin 2 to the National
Cancer Institute (NCI), which provided interleukin 2 to the institutions.
Role of the Sponsors: The Children’s
Cancer Group (CCG) was funded by an NIH U-10 grant to perform clinical trials
and correlative biology studies and epidemiologic studies in childhood cancer.
CCG-2961 was designed by the CCG-2961 Study Committee, which Dr Lange chaired.
The Committee reported to the CCG-AML Strategy Group. The design and conduct
of the study were reviewed by a data and safety monitoring board composed
of CCG and non-CCG cooperative group investigators, an ethicist, a lay member,
and representatives of the Clinical Trials Evaluation Program of the NCI,
who were nonvoting members. Primary patient data were obtained by nurses and
physicians; most were CCG members who were not compensated by CCG for their
work. Clinical research associates, supported fully or in part by the CCG
institutional grant, abstracted the data and transmitted them to the CCG Operations
office, Arcadia, Calif. Dr Lange received copies of all data capture forms.
Primary data analyses were performed by Dr Alonzo and Mr Gerbing, CCG statisticians.
The interpretation of the data was the primary responsibility of these 2 statisticians
and Dr Lange, with all authors participating substantially in the interpretation
of the data. All authors except Dr Skolnik, Ms Sacks, and Mr Gerbing were
members of the CCG-2961 committee. In 2000, CCG and 3 other groups conducting
clinical research in pediatric oncology fused to become the Children’s
Oncology Group (COG). The manuscript was sent to COG for final review by the
COG editor, Shaun Mason. Submission of the manuscript by Mr Mason to the journal
constitutes approval of the manuscript by COG. Chiron had no role in the design,
conduct, or analysis of the study.
Acknowledgment: We thank Christine Curran for
typing the manuscript and Shaun Mason, BA, for editorial support.