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NCT00923351 · ClinicalTrials.gov registry record · Phase 1
Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT00923351: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923351 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923351, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
Background: * Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often difficult to cure with standard treatment. * Immune therapy using an experimental vaccine made from proteins from the patient's tumor cells may boost the body's immune response against the tumor. * The effects of chemotherapy on the immune system can potentially make immunotherapy more effective if administered soon after completion of chemotherapy. The addition of recombinant human IL-7 (interleukin 7) (rhIL-7 (recombinant human interleukin 7)) may make the immunotherapy more effective. Objectives: -To determine whether immune therapy given after immune suppression can help the body fight the tumor and to determine the safety of the treatment. Eligibility: -Patients with solid tumors, i.e., Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose disease has recurred after treatment or spread beyond the original site Design: * Patients undergo tumor biopsy (removal of a piece of tumor tissue) to collect tumor cells for making a vaccine from proteins in the patient's tumor and apheresis (removal of a quantity of white blood cells) to collect white cells for re-building the immune system after immune therapy. Apheresis is repeated three times during immunotherapy (weeks 8, 14 and 20). * After receiving standard chemotherapy for their tumor (and an additional course of fludarabine and cyclophosphamide to further suppress immunity if needed) patients receive immune therapy in Cohorts A and B. rhIL-7 is given 48 hours before the vaccine, as an injection under the skin in an extremity that will not be used for the vaccine in patients in Cohort B only. You will be watched closely for 6 hours after the rhIL-7 for any signs of reaction. rhIL-7 will be given before vaccine doses #1, #2, #3, and #4. The vaccine is given at study weeks 2, 4, 6, 8, 10 and 12. Each vaccine is given as a total of six separate rhIL-7 followed by injections: three intradermal (like a (tuberc
Interventions
- DRUG Tumor Purged/CD25 Depleted Lymphocytes
- BIOLOGICAL Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine
- DRUG rhIL-7
- BIOLOGICAL Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2007-06-02 |
| Est. Completion | 2018-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923351
The ClinicalTrials.gov registry entry for NCT00923351 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Tumor Purged/CD25 Depleted Lymphocytes is the first listed.
NCT00923351 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923351 about?
NCT00923351 is a clinical study titled "Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma". Background: * Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often difficult to cure with standard treatment. * Immune therapy using an experimental vaccine made from proteins from the patient's tumor cells may boost the body's immune response against the tumor. *...
What is the current status of trial NCT00923351?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2007-06-02. Estimated completion is 2018-05-15.
What interventions are being tested in trial NCT00923351?
The interventions under investigation include: Tumor Purged/CD25 Depleted Lymphocytes (DRUG), Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine (BIOLOGICAL), rhIL-7 (DRUG), Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00923351?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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