Trial · NCT00432094
Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
NCT00432094, Phase 2, Completed, Masonic Cancer Center, University of Minnesota; results first posted 2022-05-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors. Trials, record NCT00432094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00432094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors
- NCT number
- NCT00432094
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Childhood Germ Cell Tumor, Ovarian Cancer, Teratoma
- Interventions
- carboplatin, etoposide, ifosfamide, paclitaxel, thiotepa, autologous hematopoietic stem cell transplantation, Mesna, filgrastim
- First posted
- 2007-02-07
- Last updated
- 2022-05-17
- Results first posted
- 2022-05-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | 1 Year | The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. |
| Secondary | Disease-free Survival (DFS) | 1 Year | The number of patients who survive without any signs of symptions of that cancer or any other cancer. |
| Secondary | Engraftment of Platelets | Day 100 | Platelet engraftment is defined as 20,000/mm\^3 (20 x 10\^9/L) for 3 consecutive days unsupported by a platelet transfusion. |
| Secondary | Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells | Pre-Transplant | Number of patients unable to achieve adequate stem cell mobilization, need to undergo one or tandem transplantation. Stem cell mobilization = A process in which certain drugs are used to cause the movement of stem cells from the bone marrow into the blood. The stem cells can be collected and stored. They may be used later to replace the bone marrow during a stem cell transplant. |
| Secondary | Engraftment of Neutrophils | Day 42 | Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm3 (0.5 x 109/L) or greater. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | 1 Year | The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups. | percentage of participants | MEAN |
| SECONDARY | Disease-free Survival (DFS) | 1 Year | The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups. | percentage of participants | MEAN |
| SECONDARY | Engraftment of Platelets | Day 100 | The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups. | participants | NUMBER |
| SECONDARY | Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells | Pre-Transplant | The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Engraftment of Neutrophils | Day 42 | The protocol is essentially one single-arm, but patients received either one or two transplants depending on the cells they had available and we are reporting results for these two groups. | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Overall Survival (OS) | 2 Transplants | 86 | 95% Confidence Interval 54 to 96 | percentage of participants | |
| Overall Survival (OS) | 1 Transplant | 56 | 95% Confidence Interval 20 to 80 | percentage of participants | |
| Disease-free Survival (DFS) | 2 Transplants | 64 | 95% Confidence Interval 34 to 83 | percentage of participants | |
| Disease-free Survival (DFS) | 1 Transplant | 44 | 95% Confidence Interval 14 to 72 | percentage of participants | |
| Engraftment of Platelets | 2 Transplants | 13 | participants | ||
| Engraftment of Platelets | 1 Transplant | 8 | participants | ||
| Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells | 2 Transplants | 0 | Participants | ||
| Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells | 1 Transplant | 0 | Participants | ||
| Engraftment of Neutrophils | 2 Transplants | 13 | Participants | ||
| Engraftment of Neutrophils | 1 Transplant | 9 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2 Transplants | 14 | |
| Overall Study | STARTED | 1 Transplant | 9 | |
| Overall Study | COMPLETED | 2 Transplants | 14 | |
| Overall Study | COMPLETED | 1 Transplant | 9 | |
| Overall Study | NOT COMPLETED | 2 Transplants | 0 | |
| Overall Study | NOT COMPLETED | 1 Transplant | 0 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Relapse | Investigations | 2 Transplants/1 Transplant Arms (Overall) | 6 | 23 | 7 |
| serious | Progressive Disease | Investigations | 2 Transplants/1 Transplant Arms (Overall) | 3 | 23 | 3 |
| serious | Death | Investigations | 2 Transplants/1 Transplant Arms (Overall) | 1 | 23 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2 Transplants/1 Transplant Arms (Overall) | 6 | 23 |
| Total, other adverse events | 2 Transplants/1 Transplant Arms (Overall) | 0 | 23 |
| Total, serious adverse events | 2 Transplants/1 Transplant Arms (Overall) | 8 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 2 Transplants vs 1 Transplant: Numbers of Patients Unable to Mobilize Peripheral Blood Stem Cells | Trial comparisons |
| 2 Transplants vs 1 Transplant: Engraftment of Platelets | Trial comparisons |
| 2 Transplants vs 1 Transplant: Engraftment of Neutrophils | 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/NCT00432094
GET https://conductscience.org/api/trials/v1/NCT00432094/registered