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NCT01953900 · ClinicalTrials.gov registry record · Phase 1

iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma

A Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Baylor College of Medicine.

Active
Registry status
Phase 1
Development phase
26
Enrollment target
2
Study locations

NCT01953900: Active Phase 1 study of Neuroblastoma and Osteosarcoma, sponsored by Baylor College of Medicine.

NCT01953900 is a Phase 1 study of Neuroblastoma and Osteosarcoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 26 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01953900, a Phase 1 study of Neuroblastoma and Osteosarcoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
26 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma. Because there is no standard treatment for recurrent/refractory osteosarcoma and neuroblastoma at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that a new gene can be put into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if a new gene can be put in these cells that will let the T cells recognize and kill sarcoma and neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live longer. Investigators have found that CAR-T cells can kill some of the tumor, but they don't last very long in the body and so the tum

Primary Outcome

The primary objective is to evaluate the safety and feasibility of intravenous injections of autologous iC9-GD2-CAR-VZV-CTLs in combination with VZV vaccination in patients with advanced GD2-positive sarcomas or neuroblastoma.

Conditions Studied

Neuroblastoma Osteosarcoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • GENETIC GD2 T cells
  • BIOLOGICAL VZV vaccine

Study Locations (2)

Texas

  • Houston Methodist Hospital - Houston
  • Texas Children's Hospital - Houston

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2014-04
Est. Completion 2034-10-31
Phase Phase 1
Baylor College of Medicine

616 total trials

What the registry record for NCT01953900 still lists

NCT01953900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT01953900 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01953900 about?

NCT01953900 is a clinical study titled "iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma". The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might ...

What is the current status of trial NCT01953900?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2014-04. Estimated completion is 2034-10-31.

What conditions does trial NCT01953900 study?

This clinical trial studies the following conditions: Neuroblastoma, Osteosarcoma.

What interventions are being tested in trial NCT01953900?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), GD2 T cells (GENETIC), VZV vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01953900?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01953900 being conducted?

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

Learn More About Clinical Trials

Similar trials for Neuroblastoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01953900's enrollment target sits among peer trials

26 65th of 94 higher than 29 of 94 other Neuroblastoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01953900, the US trial registry maintained by the National Library of Medicine. NCT01953900 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.