Nab-paclitaxel in Combination with Gemcitabine for Pediatric Relapsed and Refractory Solid Tumors

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Emory University

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a research study for people who have a solid tumor that was not effectively treated by conventional therapy or for which there is no known effective therapy. This is a phase I study of a drug called nab-paclitaxel used together with gemcitabine. Gemcitabine and nab-paclitaxel will be given intravenously, once a week for 3 out of 4 weeks, for a 28-day cycle. The goals of this study are: * To find the highest dose of nab-paclitaxel that can be safely given in combination with gemcitabine without causing severe side effects * To learn what kind of side effects nab-paclitaxel given in combination with gemcitabine can cause * To learn more about the pharmacology (how the body handles the drug) of nab-paclitaxel given in combination with gemcitabine * To evaluate tumor tissue for levels of certain proteins that may help with predicting who will benefit most from treatment with nab-paclitaxel * To determine whether nab-paclitaxel given in combination with gemcitabine is a beneficial treatment for relapsed and/or refractory solid tumors

Eligibility Criteria

This trial is for children and young adults aged 6 months to 30 years with solid tumors that haven't responded to standard treatments or have no known effective therapy. Participants must have recovered from previous cancer therapies, meet specific blood count criteria, and not have received certain drugs recently. Pregnant or breastfeeding females are ineligible, as are those unable to follow the study's safety requirements.

Inclusion Criteria

I am between 6 months and 30 years old.

My cancer has returned or didn't respond to treatment, but it's not a brain tumor.

My brain tumor was treated and has been stable for at least 3 months.

+9 more

Exclusion Criteria

I am not taking any medications that are not allowed in the study.

I am not pregnant, breastfeeding, and if of childbearing age, I have a negative pregnancy test and agree to use contraception.

Patients with any of the following adverse events at the time of enrollment are not eligible

Participant Groups

The study tests nab-paclitaxel in combination with gemcitabine on a weekly basis for three weeks followed by a rest week in a 28-day cycle. It aims to determine the safest high dose without severe side effects, understand side effects and drug handling by the body, check protein levels in tumor tissue for treatment prediction, and assess effectiveness against relapsed/refractory solid tumors.

1Treatment groups

Experimental Treatment

Group I: Gemcitabine + Nab-paclitaxelExperimental Treatment2 Interventions

Participants receiving gemcitabine and nab-paclitaxel for refractory and/or relapsed solid tumors of childhood.

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Gemzar for: