Crizotinib and Combination Chemotherapy in Treating Younger Patients With Relapsed or Refractory Solid Tumors or Anaplastic Large Cell Lymphoma
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.
Timeline
- Start
- 2013-04-29
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
Publications
- Bartlett JA, Culver N, Santangelo M, Prpich A, Long E, Sagawa K, Shanker R, Xu H, Wilner K. Development of a Taste-Masked, Dose-Flexible, Multiparticulate Pediatric Dosage Form: Case Study of Crizotinib, a Challenging Pediatric Formulation. Pharmaceut Med. 2026 May;40(3):193-207. doi: 10.1007/s40290-026-00604-2. Epub 2026 Apr 1.
- Greengard E, Mosse YP, Liu X, Minard CG, Reid JM, Voss S, Wilner K, Fox E, Balis F, Blaney SM, Adamson PC, Weigel BJ. Safety, tolerability and pharmacokinetics of crizotinib in combination with cytotoxic chemotherapy for pediatric patients with refractory solid tumors or anaplastic large cell lymphoma (ALCL): a Children's Oncology Group phase 1 consortium study (ADVL1212). Cancer Chemother Pharmacol. 2020 Dec;86(6):829-840. doi: 10.1007/s00280-020-04171-4. Epub 2020 Oct 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crizotinib | Small molecule | 165 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 215 mg/m2 | Oral |
| Subject | Crizotinib | Small molecule | 280 mg/m2 | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Dexrazoxane | Small molecule | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Topotecan | Small molecule | — | — |
| Background | Vincristine | Small molecule | — | — |