CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
Crizotinib +8 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01606878
NCT01606878Phase 1Completed

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

Children's Oncology Group·interventional·Posted May 28, 2012·Updated Jan 5, 2024

In Brief

A Phase 1 clinical trial evaluating Crizotinib, Cyclophosphamide, and 7 other interventions for Childhood Solid Neoplasm and 2 related conditions. Completed, enrolled 46 participants across 23 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 28, 2012
Enrollment StartApr 29, 2013
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.1 years ago

Interventions

Crizotinibdrug

Given PO

Cyclophosphamidedrug

Given IV

Dexrazoxane Hydrochloridedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Questionnaire Administrationother

Ancillary studies

Topotecan Hydrochloridedrug

Given IV

Vincristine Sulfatedrug

Given IV