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NCT02446431 · ClinicalTrials.gov registry record · Early Phase 1

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence

A Early Phase 1 study of Solid Tumor, sponsored by Miller Children's & Women's Hospital Long Beach.

Recruiting
Registry status
Early Phase 1
Development phase
20
Enrollment target
2
Study locations

NCT02446431 is a Early Phase 1 study of Solid Tumor that is actively recruiting participants, run by Miller Children's & Women's Hospital Long Beach. The registered enrollment target is 20 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT02446431, a Early Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Miller Children's & Women's Hospital Long Beach.

RECRUITING
Registry status
Early Phase 1
Development phase
20 participants
Enrollment target
2
Study locations

Study Summary

Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug exposure, has been successfully tested in pediatric leukemias with excellent results in terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with little success, but has been implemented usually in the relapsed setting at a time of high tumor burden and disease resistance.

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Bevacizumab
  • DRUG Valproic Acid
  • DRUG Temsirolimus

Study Locations (2)

California

  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Orange County - Orange

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2014-07
Est. Completion 2029-07
Phase Early Phase 1

What the Registry Record Tells You About NCT02446431

The ClinicalTrials.gov registry entry for NCT02446431 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (91% lower). The listed sponsor is Miller Children's & Women's Hospital Long Beach, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT02446431 reports 2 study locations spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT02446431 about?

NCT02446431 is a clinical study titled "Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence". Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metrono...

What is the current status of trial NCT02446431?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2014-07. Estimated completion is 2029-07.

What conditions does trial NCT02446431 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT02446431?

The interventions under investigation include: Cyclophosphamide (DRUG), Bevacizumab (DRUG), Valproic Acid (DRUG), Temsirolimus (DRUG).

Who is sponsoring clinical trial NCT02446431?

This trial is sponsored by Miller Children's & Women's Hospital Long Beach, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02446431 being conducted?

This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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