Trial · NCT00467051
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
NCT00467051, Phase 2, Completed, Children's Oncology Group; results first posted 2015-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors. Trials, record NCT00467051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467051
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
- NCT number
- NCT00467051
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
Childhood Extracranial Germ Cell Tumor, Childhood Extragonadal Malignant Germ Cell Tumor, Childhood Malignant Ovarian Germ Cell Tumor, Childhood Malignant Testicular Germ Cell Tumor, Ovarian Choriocarcinoma, Ovarian Embryonal Carcinoma, Ovarian Yolk Sac Tumor, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Testicular Choriocarcinoma, Testicular Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Embryonal Carcinoma, Testicular Mixed Choriocarcinoma and Yolk Sac Tumor, Testicular Mixed Embryonal Carcinoma and Yolk Sac Tumor, Testicular Yolk Sac Tumor
- Interventions
- Carboplatin, Filgrastim, Ifosfamide, Laboratory Biomarker Analysis, Paclitaxel
- First posted
- 2007-04-27
- Last updated
- 2018-08-29
- Results first posted
- 2015-03-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days) | Patients who demonstrate a PR or CR, as defined below, will be considered as responders. RECIST criteria: CR (complete response) = disappearance of all target lesions, PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions, PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions and SD (stable disease) = small changes that do not meet above criteria. |
| Secondary | The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. | Two cycles of chemotherapy; expected to be 42 days of treatment. |
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 Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | At baseline (day 1) and after completion of protocol therapy (2 cycles or 42 days) | participants | NUMBER | |
| SECONDARY | The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. | Two cycles of chemotherapy; expected to be 42 days of treatment. | All eligible patients. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Treatment (Chemotherapy, Biological Therapy) | Responder | 12 | participants | |
| Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria | Treatment (Chemotherapy, Biological Therapy) | Non-Responder | 8 | participants | |
| The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. | Experimental | 18 | Participants |
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 | Treatment (Chemotherapy, Biological Therapy) | 20 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy, Biological Therapy) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy, Biological Therapy) | 2 |
Source ClinicalTrials.gov
Adverse events25
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 | Agitation | Psychiatric disorders | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Chemotherapy, Biological Therapy) | 2 | 20 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Chemotherapy, Biological Therapy) | 8 | 20 | |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Ataxia | Nervous system disorders | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Bladder infection | Infections and infestations | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Cardiac disorders - Other | Cardiac disorders | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Confusion | Psychiatric disorders | Treatment (Chemotherapy, Biological Therapy) | 1 | 20 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Chemotherapy, Biological Therapy) | 5 | 20 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Chemotherapy, Biological Therapy) | ||
| Total, other adverse events | Treatment (Chemotherapy, Biological Therapy) | 18 | 20 |
| Total, serious adverse events | Treatment (Chemotherapy, Biological Therapy) | 0 | 20 |
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
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/NCT00467051
GET https://conductscience.org/api/trials/v1/NCT00467051/events?page=2