Nab-paclitaxel followed by Gemcitabine Hydrochloride in Treating Pediatric Participants with Newly-Diagnostic, Relapsed or Refractory Solid Tumors

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT03507491
Trial Phases:	Phase I	Protocol IDs:	AFLACST1603 (primary) NCI-2018-00465 IRB00098777
Eligibility:	6 Months - 30 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Children's Healthcare of Atlanta - Egleston
NCI Full Details:	http://clinicaltrials.gov/show/NCT03507491

Summary

This phase I trial studies the side effects and best dose of nab-paclitaxel when given together with gemcitabine hydrochloride in treating pediatric participants with solid tumors that are newly-diagnostic, have come back (relapsed), or do not respond to treatment (refractory). Nab-paclitaxel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, or by stopping them from dividing, or by stopping them from spreading. Giving nab-paclitaxel in combination with gemcitabine hydrochloride, may work better in treating pediatric participants with solid tumors.

Objectives

PRIMARY OBJECTIVES:
I. To estimate the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) of nab-paclitaxel administered intravenously weekly every 3 of 4 weeks in combination with gemcitabine hydrochloride in children with refractory/relapsed non-central nervous system (CNS) solid tumors.
II. To define and describe the toxicities of nab-paclitaxel in combination with gemcitabine hydrochloride administered on this schedule.

SECONDARY OBJECTIVES:
I. To preliminarily define the anti-tumor activity of nab-paclitaxel in combination with gemcitabine hydrochloride within the confines of a phase 1 study.
II. To evaluate the expression of secreted protein acidic and rich in cysteine (SPARC) in tumor tissue from pediatric solid tumors and correlate this with response to therapy.
III. To determine the pharmacokinetic profile of nab-paclitaxel in combination with gemcitabine hydrochloride in children with refractory/relapsed non-CNS solid tumors.

OUTLINE: This is a dose escalation study of nab-paclitaxel.

Participants receive nab-paclitaxel intravenously (IV) over 30 minutes and gemcitabine hydrochloride IV over 60 minutes on days 1, 8, and 15. Cycles repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up periodically.

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

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