PEDIATRIC ONCOLOGY GROUP - PHASE I TRIALS IN CHILDREN
Project Number1U01CA057745-01
Contact PI/Project LeaderVIETTI, TERESA J.
Awardee OrganizationWASHINGTON UNIVERSITY
Description
Abstract Text
The POG wishes to continue timely performance of phase I studies of new
cytotoxic, biologic, and maturational agents in children with advanced
disease resistant to standard therapy. The MTD achieved and the associated
toxicities will determine the dose, supportive care and precautions to be
used in phase II trials in children. Pharmacokinetic and pharmacodynamic
studies will be done on children at the starting dose, when there is
evidence of a biologic effect and at the MTD. Biological assays will be
obtained if a biological response modifier or maturational agent is under
investigation. The starting dose level will be determined after
consultation with the CTEP drug monitor. If the starting dose is 80% of
the MTD in adults, the subsequent escalation of doses will be 20%. If
phase I studies have not been done in adults then the starting dose will be
1/10 of the LD10 in mice (or 1/3 of the TDL in large animals) and a
modified Fibonacci scheme will be used for dose escalation. Investigators
will submit all data forms at weekly intervals to the Study Chairman and
the Scientific Administrator. The Study Chairman and the CTEP drug monitor
will be notified by telephone of any unusual, unexpected, unacceptable,
previously unreported toxicity, or death on study. Every three months the
Study Chairman will prepare a summary of the patients entered at each dose
level, the toxicity observed, and the pharmacologic data for biologic
studies obtained and send a copy to the Phase I Subcommittee Chairman and
the Scientific Administrator. The Phase I Subcommittee Chairman will
review these and submit them to the Phase I Chairman and the CTEP. Every
six months, compliance to protocol requirements and timeliness of data
submission will be reviewed by the Phase I Compliance Committee. Six
months after the last patient entry, a manuscript will be prepared and
submitted to the Writing Committee. All institutions entering patients on
protocol will be audited at least once every three years.
No Sub Projects information available for 1U01CA057745-01
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