Clinical Trial: Denileukine Diftitox for Relapsed ALCL

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Pilot Multicenter Study of Denileukin Diftitox Alone and in Combination With ICE (ICED) Chemotherapy in Children, Adolescents and Young Adults (CAYA) With Relapsed or Refractory

Brief Summary: The purpose of this study is to determine is Denileukin diftitox will be safe, well tolerated and induce a significant overall response alone and in combination with chemotherapy: ifosfamide, carboplatin and etoposide (ICE) and will be safe and well tolerated in a population of children, adolescents and young adults with relapsed or refractory anaplastic large cell lymphoma (ALCL).

Detailed Summary: Despite significant progress in the treatment and outcome for childhood ALCL, the prognosis for children who develop progressive or recurrent disease is poor with < 30% DFS. Novel therapies are urgently needed for these subgroups of patients. One potential approach is the investigation of a new class of receptor targeted cytotoxic fusion proteins (denileukin diftitox{DD}). We have previously demonstrated that > 85% of children with ALCL express CD25. The human IL-2 receptor exists in three forms, low (CD25), intermediate (CD122/CD132) and high (CD25/CD122/CD132) affinity. DD is a recombinant DNA-derived cytotoxic fusion protein composed of the amino acid sequences for diphtheria toxin fragments followed by the binding sequences for the interleukin-2 receptor. Malignant cells expressing one or more of the subunits of the IL-2 receptor are found in certain leukemias and lymphomas including cutaneous T-cell lymphoma (CTCL). Clinical studies have shown therapeutic efficacy of DD alone and in combination with CHOP chemotherapy in CD25 expressing malignancies such as CTCL, CLL and lymphoma. We hypothesize that DD will be safe and efficacious in children with relapsed ALCL.
Sponsor: Columbia University

Current Primary Outcome:

  • Toxicity [ Time Frame: 5 months ]
  • Determine response rate [ Time Frame: 6 months ]
  • Evaluate safety of combination of Denileukin Diftitox and ICE chemotherapy [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Biology Studies of ALCL [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: December 3, 2008
Date Started: December 2008
Date Completion: June 2012
Last Updated: May 14, 2013
Last Verified: October 2009