ADV1212: Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

A Phase I Study of Crizotinib (IND# 105573) in Combination with Conventional Chemotherapy for Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma

Categories:

Solid Tumor

Leukemia / Lymphoma

Phase I/II

Diseases Treated:

Relapsed or refractory solid tumors or anaplastic large cell lymphoma

Eligibility Overview:

  • Participant is > than 12 month and < 21 years of age at the time of enrollment.
  • Participant has histologic verification at original diagnosis or relapse or relapse of relapsed or refractory solid tumor or anaplastic large cell lymphoma (ALCL).
  • Participant does not have primary or metastatic CNS tumor.
  • Participant has not received prior therapy with crizotinib.

Description

This is a Phase I study of a drug called crizotinib in combination with chemotherapy.

Crizotinib is considered experimental because we are not sure if it will work on this disease in humans. This is called a Phase I study because the goal is to find the highest dose of crizotinib in combination with chemotherapy  (cyclophosphamide and topotecan)  that we can give safely. One group will take crizotinib in capsule form (swallowed whole), and the other will get crizotinib in a form that can be mixed in water.

Objectives

  • To find the highest safe dose of crizotinib that can be given in combination with standard chemotherapy drugs without causing severe side effects.
  • To learn what kind of side effects crizotinib in combination with standard chemotherapy drugs can cause.
  • To learn more about the pharmacology (how your body handles the drug) of crizotinib in combination with standard chemotherapy drugs.
  • To learn more about the biology of crizotinib in combination with standard chemotherapy drugs.
  • To determine whether crizotinib in combination with standard chemotherapy drugs is a beneficial treatment for relapsed or refractory solid tumors anaplastic large cell lymphoma.

Eligibility criteria, among others include:

  • Participant is > 12 months and < 21 years of age at the time of enrollment.
  • Participant has histologic verification at original diagnosis or relapse or relapse of relapsed or refractory solid tumor or anaplastic large cell lymphoma (ALCL).
  • Participant does not have primary or metastatic CNS tumor.
  • Participant has fully recovered from the acute toxic effects of all prior anti-cancer therapy.
  • Participant has not received prior therapy with crizotinib.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Wayne Furman, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.