Trial · NCT00923351
Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
NCT00923351, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-09-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma. Trials, record NCT00923351. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923351
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
- NCT number
- NCT00923351
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Neuroblastoma, Sarcoma, Rhabdomyosarcoma-Embryonal, Rhabdomyosarcoma- Alveolar, Neuroectodermal Tumors, Primitive, Peripheral
- Interventions
- Tumor Purged/CD25 Depleted Lymphocytes, Tumor Purged/CD25 Depleted Lymphocytes with Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine, rhIL-7, Tumor Lysate/KLH Pulsed Dendritic Cell Vaccine
- First posted
- 2009-06-18
- Last updated
- 2018-06-15
- Results first posted
- 2013-09-20
- Limitations and caveats
Re: Reason stopped: Of 30 pts who have received immunotherapy,12 remain on F/U, are stable or without evidence of disease,11 died of PD, 7 are currently receiving additional therapy (NOT ON THIS PROTOCOL) for PD.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay | Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B) | 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 pediatric solid tumors such as Ewing's sarcoma, rhabdomyosarcoma, or neuroblastoma. Each vaccine is given as 6 separate injections. Three intradermal on one arm or leg and three subcutaneous on the other arm or leg. |
| Primary | Toxicity | Date treatment consent signed to date off study, approximately 49.5 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| Primary | Overall Survival | Time between the first day of treatment to the day of death or at the conclusion of 5 years of follow-up, whichever comes first, assessed up to approximately 11 years. | Overall survival is defined as the time between the first day of treatment to the day of death. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay | Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (± 7 days) (Arm B) | Five of the original six participants from Arm A were analyzed because one subject was changed to a special exemption. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Toxicity | Date treatment consent signed to date off study, approximately 49.5 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Overall Survival | Time between the first day of treatment to the day of death or at the conclusion of 5 years of follow-up, whichever comes first, assessed up to approximately 11 years. | years | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay | Arm A - Participants Who Did Not Receive rhIL-7 | 0 | Participants | ||
| Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay | Arm B - Participants Who Received rhIL-7 | 15 | Participants | ||
| Toxicity | Arm A - Participants Who Did Not Receive rhIL-7 | 6 | Participants | ||
| Toxicity | Arm B - Participants Who Received rhIL-7 | 24 | Participants | ||
| Overall Survival | Arm A - Participants Who Did Not Receive rhIL-7 | 2.4 | Full Range 1.0 to 3.3 | years | |
| Overall Survival | Arm B - Participants Who Received rhIL-7 | 4.3 | Full Range 0.9 to 10.4 | years |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - Participants Who Did Not Receive rhIL-7 | 6 | |
| Overall Study | STARTED | Arm B - Participants Who Received rhIL-7 | 26 | |
| Overall Study | STARTED | Enrolled But Not Assigned to Treatment | 12 | |
| Overall Study | COMPLETED | Arm A - Participants Who Did Not Receive rhIL-7 | 6 | |
| Overall Study | COMPLETED | Arm B - Participants Who Received rhIL-7 | 26 | |
| Overall Study | COMPLETED | Enrolled But Not Assigned to Treatment | 0 | |
| Overall Study | NOT COMPLETED | Arm A - Participants Who Did Not Receive rhIL-7 | 0 | |
| Overall Study | NOT COMPLETED | Arm B - Participants Who Received rhIL-7 | 0 | |
| Overall Study | NOT COMPLETED | Enrolled But Not Assigned to Treatment | 12 |
Source ClinicalTrials.gov
Adverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Arm A - Participants Who Did Not Receive rhIL-7 | 3 | 6 | 3 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | Arm B - Participants Who Received rhIL-7 | 8 | 26 | 16 |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Arm A - Participants Who Did Not Receive rhIL-7 | 3 | 6 | 3 |
| other | AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | Arm B - Participants Who Received rhIL-7 | 9 | 26 | 18 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Arm A - Participants Who Did Not Receive rhIL-7 | 1 | 6 | 1 |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Arm B - Participants Who Received rhIL-7 | 10 | 26 | 20 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Arm A - Participants Who Did Not Receive rhIL-7 | 4 | 6 | 4 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Arm B - Participants Who Received rhIL-7 | 5 | 26 | 9 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm A - Participants Who Did Not Receive rhIL-7 | 0 | 6 | 0 |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Arm B - Participants Who Received rhIL-7 | 3 | 26 | 3 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - Participants Who Did Not Receive rhIL-7 | 0 | 6 |
| Total, all-cause mortality | Arm B - Participants Who Received rhIL-7 | 1 | 26 |
| Total, other adverse events | Arm A - Participants Who Did Not Receive rhIL-7 | 6 | 6 |
| Total, other adverse events | Arm B - Participants Who Received rhIL-7 | 24 | 26 |
| Total, serious adverse events | Arm A - Participants Who Did Not Receive rhIL-7 | 6 | 6 |
| Total, serious adverse events | Arm B - Participants Who Received rhIL-7 | 12 | 26 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: Number of Participants With a Positive Immune Response as Evidenced by the Delayed Type of Hypersensitivity (DTH) Reaction Assay | Trial comparisons |
| Arm A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: Toxicity | Trial comparisons |
| Arm A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: deaths from any cause | Trial comparisons |
| Arm A - Participants Who Did Not Receive rhIL-7 vs Arm B - Participants Who Received rhIL-7: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00923351
GET https://conductscience.org/api/trials/v1/NCT00923351/events?page=2