OncRef

Clinical Trial: NCT01606878

Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Children's Oncology Group
Information Provided By:Children's Oncology Group
Last Update Posted:2024-01-05

Study Overview

Brief Summary

This phase I trial studies the side effects and the best dose of crizotinib when given together with combination chemotherapy in treating younger patients with solid tumors or anaplastic large cell lymphoma that has returned or does not respond to treatment. Crizotinib may stop the growth of tumor or cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, topotecan hydrochloride, dexrazoxane hydrochloride, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving crizotinib together with combination chemotherapy may be a better treatment for patients with solid tumors or anaplastic large cell lymphoma.

Official Title

A Phase 1 Study of Crizotinib in Combination With Conventional Chemotherapy for Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Conditions

Childhood Solid Neoplasm, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Neuroblastoma

Intervention / Treatment

  • Drug: Crizotinib
  • Drug: Cyclophosphamide
  • Drug: Dexrazoxane Hydrochloride
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Other: Questionnaire Administration
  • Drug: Topotecan Hydrochloride
  • Drug: Vincristine Sulfate

Other Study ID Numbers

  • ADVL1212
  • NCI-2012-01968
  • CDR0000734059
  • ADVL1212
  • ADVL1212
  • ADVL1212
  • UM1CA097452

Start Date (Actual)

2013-04-29

Primary Completion Date (Actual)

2018-12-31

Study Completion Date (Actual)

2018-12-31

Enrollment (Actual)

46

Study Type

Interventional

Phase

Phase 1