Trial · NCT00001566
A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
NCT00001566, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas. Trials, record NCT00001566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001566
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas
- NCT number
- NCT00001566
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Ewing's Sarcoma, Rhabdomyosarcoma
- Interventions
- therapeutic autologous dendritic cells, indinavir sulfate, peripheral blood stem cell transplantation
- First posted
- 1999-11-04
- Last updated
- 2012-06-15
- Results first posted
- 2012-06-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution | 20 weeks post vaccination | Immune response was defined as a percent specific lysis of \>10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)\*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)\* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides. |
| Primary | The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy | 2 to 6 months | CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been \<10 years of age and sustained a CD4 count of \<300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count \> 500 cells/mcl at any timepoint within 6 months of completing chemotherapy. |
| Primary | Number of Participants With an Immune Response to the Translocation Breakpoint Peptide | 5 years | Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines. |
| Primary | Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7 | 5 years | Immune response was defined as a percent specific lysis of \>10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0. |
| Primary | Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation | Once per enrollment | Immune response was defined as a percent specific lysis of \>10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets \>2-fold that found with no-peptide controls or a proliferation index \>3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)\*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)\* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides. |
| Secondary | Percentage of Participants Overall Survival | 5 years | Overall survival is defined as the time between the first day of treatment to the day of death. |
| Secondary | Percent of Participants: Event Free Survival | 5 years | Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease. |
| Secondary | Number of Participants With Adverse Events | 5 years | Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
| Secondary | Median Overall Survival | 5.4 years | Overall survival is defined as the time between the first day of treatment to the day of death. |
Source ClinicalTrials.gov
Outcomes9
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 an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution | 20 weeks post vaccination | Participants | NUMBER | |
| PRIMARY | The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy | 2 to 6 months | Percentage of participants | NUMBER | |
| PRIMARY | Number of Participants With an Immune Response to the Translocation Breakpoint Peptide | 5 years | Participants | NUMBER | |
| SECONDARY | Percentage of Participants Overall Survival | 5 years | Percentage of participants | NUMBER | |
| SECONDARY | Percent of Participants: Event Free Survival | 5 years | Percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 5 years | Participants | NUMBER | |
| PRIMARY | Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7 | 5 years | 12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides. | Participants | NUMBER |
| PRIMARY | Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation | Once per enrollment | Participants | NUMBER | |
| SECONDARY | Median Overall Survival | 5.4 years | Years | MEDIAN |
Source ClinicalTrials.gov
Results by group10
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 an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | Immune response to tumor specific peptides | 9 | Participants | |
| Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | Immune response to non-tumor specific peptides | 23 | Participants | |
| The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 12.5 | Percentage of participants | ||
| Number of Participants With an Immune Response to the Translocation Breakpoint Peptide | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 9 | Participants | ||
| Percentage of Participants Overall Survival | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 43 | Percentage of participants | ||
| Percent of Participants: Event Free Survival | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 31 | Percentage of participants | ||
| Number of Participants With Adverse Events | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 27 | Participants | ||
| Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7 | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 3 | Participants | ||
| Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 5 | Participants | ||
| Median Overall Survival | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 4.1 | Full Range 3.4 to 5.4 | Years |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 42 | |
| Overall Study | Completed Immunotherapy | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 23 | |
| Overall Study | COMPLETED | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 23 | |
| Overall Study | NOT COMPLETED | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 19 |
Source ClinicalTrials.gov
Adverse events243
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 | Abdominal discomfort | Gastrointestinal disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 2 | 42 | 5 |
| other | Achiness | Musculoskeletal and connective tissue disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 1 |
| other | Achy | General disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 1 |
| other | Acid reflux | Gastrointestinal disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 6 |
| other | Acne (rash) on chest | Skin and subcutaneous tissue disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 4 |
| other | Alkaline phosphate elevated | Metabolism and nutrition disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 7 | 42 | 10 |
| other | ALT (SGPT) | Metabolism and nutrition disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 1 | 42 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 6 | 42 | 9 |
| other | Anxiety | Psychiatric disorders | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 2 | 42 | 2 |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | ||
| Total, other adverse events | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 27 | 42 |
| Total, serious adverse events | Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy | 15 | 42 |
Source ClinicalTrials.gov
Papers5
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00001566
GET https://conductscience.org/api/trials/v1/NCT00001566/events?page=2