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NCT00953420 · ClinicalTrials.gov registry record · Phase 2

Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes

A Phase 2 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT00953420 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 20 participants.

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The verdict

NCT00953420, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come back or not gone away after the best known standard treatments. Most patients that respond to chemotherapy once their NPC tumors have come back have been treated with a platinum-based medication like cisplatin. However, since many patients are given cisplatin during their initial treatment for NPC, in this study, they will be treated with another platinum-based chemotherapy medicine that has been used in patients with NPC called carboplatin. In this study, carboplatin will be used in combination with another drug called docetaxel. Other studies in patients with advanced head and neck cancer have shown that docetaxel can cause tumors to respond better and allow patients to survive longer when added to the standard treatments for those diseases. Some patients with NPC show evidence of infection with the virus that causes infectious mononucleosis, known as the Epstein Barr virus (EBV), before or at the time of their cancer diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage disease, suggesting that it may play a role in causing NPC. Previously, patients have been treated with high-risk NPC using EBV-specific cytotoxic T cells. These cells are grown in the laboratory and taught to recognize and attack EBV infected cells. In the past, patients were either given the cells alone or just after they had received a medication to briefly lower their white blood cell count. In both cases, many patients had their tumors shrink and in some cases completely disappear after being treated with these EBV-specific cytotoxic T cells. Investigators have now decided to look at how patients with NPC and their tumors respond to the treatment combination of chemotherapy and EBV-CTL. Patients are being asked to participate in this study since the NPC tumor is associated with EBV and has either come back or not responded to standard treatment. This combination of che

Interventions

  • DRUG Carboplatin
  • DRUG Docetaxel
  • DRUG Dexamethasone
  • BIOLOGICAL EBV-specific cytotoxic T lymphocytes
  • BIOLOGICAL G-CSF or Peg-GCSF

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-11
Est. Completion 2015-07
Phase Phase 2

Sponsor

Baylor College of Medicine

616 total trials

What the Registry Record Tells You About NCT00953420

The ClinicalTrials.gov registry entry for NCT00953420 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT00953420 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00953420 about?

NCT00953420 is a clinical study titled "Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes". Patients have a type of cancer called nasopharyngeal carcinoma (NPC) that has either come back or not gone away after the best known standard treatments. Most patients that respond to chemotherapy once their NPC tumors have come back have been treated with a platinum-based medication like cisplatin...

What is the current status of trial NCT00953420?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2009-11. Estimated completion is 2015-07.

What interventions are being tested in trial NCT00953420?

The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Dexamethasone (DRUG), EBV-specific cytotoxic T lymphocytes (BIOLOGICAL), G-CSF or Peg-GCSF (BIOLOGICAL).

Who is sponsoring clinical trial NCT00953420?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.