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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). 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
Primary Outcome
A positive response to the tumor vaccine requires a positive reaction in at least one of the two assays below (immune responses to tumor lysates using ex vivo and delayed type of hypersensitivity (DTH). The presence of a positive delayed type of hypersensitivity (DTH) reaction to the tumor lysate in a patient who did not show a positive DTH reaction prior to immunotherapy. A positive reaction is induration of at least 0.5 cm. Immunotherapy administered to patients with recurrent or metastatic
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 |
What the finished NCT00923351 record still lists
NCT00923351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 4 interventions - of which Tumor Purged/CD25 Depleted Lymphocytes is the first listed.
NCT00923351 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00923351's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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