Trial · NCT00423852
Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
NCT00423852, Phase 1, Phase 2, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2016-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin. Trials, record NCT00423852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00423852
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin
- NCT number
- NCT00423852
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor
- Interventions
- filgrastim, carboplatin, ifosfamide, paclitaxel, autologous hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
- First posted
- 2007-01-18
- Last updated
- 2016-05-18
- Results first posted
- 2016-05-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response | 2 year | Response assessed at the completion of therapy (after four to five cycles of chemotherapy and after surgery if necessary) Complete Response (CR): A complete response is defined as one of the following: * Complete disappearance of all clinical and radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). * Complete disappearance of all biochemical evidence of disease with resection of residual radiographic masses that prove to be negative for residual GCT; this includes both mature teratoma and necrotic debris (CR to chemotherapy) for a minimum of 4 weeks. * Complete disappearance of all biochemical evidence of disease with complete surgical excision of all residual radiographic masses that, if pathologically positive for residual malignant GCT, show margins to microscopically free of disease (CR to chemotherapy + surgery). Patients must be free of disease for a minimum of 4 weeks. |
| Primary | Maximum Tolerated Dose of Ifosfamide | 4 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response | 2 year | participants | NUMBER | |
| PRIMARY | Maximum Tolerated Dose of Ifosfamide | 4 years | mg/m2 | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response | Chemotherapy With Stem Cell Support | Complete Response (CR) | 12 | participants | |
| Response | Chemotherapy With Stem Cell Support | Incomplete Response (IR) | 6 | participants | |
| Response | Chemotherapy With Stem Cell Support | Partial Response (PR) | 5 | participants | |
| Maximum Tolerated Dose of Ifosfamide | Chemotherapy With Stem Cell Support | 9990 | mg/m2 |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemotherapy With Stem Cell Support | 26 | |
| Overall Study | COMPLETED | Chemotherapy With Stem Cell Support | 23 | |
| Overall Study | NOT COMPLETED | Chemotherapy With Stem Cell Support | 3 |
Source ClinicalTrials.gov
Adverse events43
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 | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 19 | 26 | 63 |
| other | AST, SGOT | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 11 | 26 | 24 |
| other | Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 2 | 26 | 2 |
| other | Alkaline phosphatase | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 3 | 26 | 3 |
| other | Amylase | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 2 | 26 | 5 |
| other | Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 9 | 26 | 14 |
| other | Constipation | Gastrointestinal disorders | Chemotherapy With Stem Cell Support | 2 | 26 | 2 |
| other | Creatinine | Metabolism and nutrition disorders | Chemotherapy With Stem Cell Support | 9 | 26 | 35 |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Chemotherapy With Stem Cell Support | 12 | 26 | 20 |
| other | Febrile neutropenia | Infections and infestations | Chemotherapy With Stem Cell Support | 7 | 26 | 10 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemotherapy With Stem Cell Support | ||
| Total, other adverse events | Chemotherapy With Stem Cell Support | 26 | 26 |
| Total, serious adverse events | Chemotherapy With Stem Cell Support | 9 | 26 |
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 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/NCT00423852
GET https://conductscience.org/api/trials/v1/NCT00423852/events?page=2