Trial · NCT00002931
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
NCT00002931, Phase 2, Completed, City of Hope Medical Center; results first posted 2017-01-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer. Trials, record NCT00002931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00002931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
- NCT number
- NCT00002931
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
- Interventions
- filgrastim, carboplatin, etoposide, ifosfamide, paclitaxel, autologous bone marrow transplantation, bone marrow ablation with stem cell support
- First posted
- 2003-01-27
- Last updated
- 2017-02-23
- Results first posted
- 2017-01-04
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Until disease progression, up to 5 years. | Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers. |
| Primary | Toxic Effects | From date of randomization until death of any cause, assessed up to 12 weeks | Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy |
| Secondary | Overall Survival | Until death from any cause, up to 5 years. | Estimated using the product-limit method of Kaplan and Meier. |
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 | Progression-free Survival | Until disease progression, up to 5 years. | Months | MEAN | |
| PRIMARY | Toxic Effects | From date of randomization until death of any cause, assessed up to 12 weeks | participants | NUMBER | |
| SECONDARY | Overall Survival | Until death from any cause, up to 5 years. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | HD Chemo and Auto Stem Cells | 11.8 | 95% Confidence Interval 5.8 to NA | Months | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Hyperglycemia | 4 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Transaminase alone | 6 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Mucositis/stomatitis | 10 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Nausea/vomiting | 5 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Febrile neutropenia | 1 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Diarrhea | 3 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Hyperbilirubinemia | 3 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Fever w/o neutropenia | 2 | participants | |
| Toxic Effects | HD Chemo and Auto Stem Cells | Hypocalcemia | 2 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HD Chemo and Auto Stem Cells | 48 | |
| Overall Study | COMPLETED | HD Chemo and Auto Stem Cells | 46 | |
| Overall Study | NOT COMPLETED | HD Chemo and Auto Stem Cells | 2 |
Source ClinicalTrials.gov
Adverse events137
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 | Cerebellar | Nervous system disorders | HD Chemo and Auto Stem Cells | 15 | 48 | 21 |
| other | Clinical (Physical Exam) | General disorders | HD Chemo and Auto Stem Cells | 13 | 48 | 20 |
| other | Dysrhythmias | Cardiac disorders | HD Chemo and Auto Stem Cells | 9 | 48 | 13 |
| other | Fluid Retention | General disorders | HD Chemo and Auto Stem Cells | 16 | 48 | 25 |
| other | Hematemesis | Gastrointestinal disorders | HD Chemo and Auto Stem Cells | 3 | 48 | 4 |
| other | Hemorrhage | Vascular disorders | HD Chemo and Auto Stem Cells | 16 | 48 | 25 |
| other | Infection | Infections and infestations | HD Chemo and Auto Stem Cells | 16 | 48 | 25 |
| other | Ischemia | Cardiac disorders | HD Chemo and Auto Stem Cells | 9 | 48 | 13 |
| other | Other Misc | General disorders | HD Chemo and Auto Stem Cells | 14 | 48 | 57 |
| other | Pericardial | Cardiac disorders | HD Chemo and Auto Stem Cells | 9 | 48 | 13 |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HD Chemo and Auto Stem Cells | ||
| Total, other adverse events | HD Chemo and Auto Stem Cells | 46 | 48 |
| Total, serious adverse events | HD Chemo and Auto Stem Cells | 1 | 48 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00002931
GET https://conductscience.org/api/trials/v1/NCT00002931/events?page=2