A phase I study of nolatrexed dihydrochloride in children with advanced cancer. A United Kingdom Children's Cancer Study Group Investigation
2001

Nolatrexed for Children with Advanced Cancer

Sample size: 16 publication Evidence: moderate

Author Information

Author(s): Estlin E J, Pinkerton C R, Lewis I J, Lashford L, McDowell H, Morland B, Kohler J, Newell D R, Boddy A V, Taylor G A, Price L, Ablett S, Hobson R, Pitsiladis M, Brampton M, Clendeninn N, Johnston A, Pearson A D J

Primary Institution: United Kingdom Children's Cancer Study Group, Department of Epidemiology and Public Health, UKCCSG Data Centre, University of Leicester

Hypothesis

Can nolatrexed dihydrochloride be safely administered to children with advanced cancer?

Conclusion

Nolatrexed can be safely administered to children with cancer, showing evidence of therapeutic activity and antiproliferative toxicity.

Supporting Evidence

  • 8 patients were evaluable for toxicity.
  • Grade 3 or 4 toxicity was observed with AUC values of >60 mg ml−1 min−1.
  • One patient had stable disease for 11 cycles of therapy.
  • Two patients with acute lymphoblastic leukaemia had a short-lived 50% reduction in peripheral lymphoblast counts.

Takeaway

Doctors tested a new medicine called nolatrexed on kids with serious cancer, and it seemed to help without making them too sick.

Methodology

A phase I study with 16 patients treated at three different dose levels of nolatrexed.

Limitations

Only a small number of patients were evaluable for toxicity.

Participant Demographics

Children with advanced malignancy.

Digital Object Identifier (DOI)

10.1054/bjoc.2000.1569

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