Trial · NCT00304083
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
NCT00304083, Phase 2, Completed, Sarcoma Alliance for Research through Collaboration; results first posted 2018-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors. Trials, record NCT00304083. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00304083
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
- NCT number
- NCT00304083
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Sarcoma Alliance for Research through Collaboration
- Conditions
- Neurofibromatosis Type 1, Sarcoma
- Interventions
- filgrastim, doxorubicin hydrochloride, etoposide, ifosfamide, conventional surgery, radiation therapy
- First posted
- 2006-03-17
- Last updated
- 2018-09-18
- Results first posted
- 2018-05-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Response Rate (Complete Response and Partial Response) | After 4 Cycles (1 cycle=21 days) | WHO criteria was used to determine responses due to the nonspherical shape of most MPNST. Complete Response (CR), Disappearance of all target lesions; Partial response (PR), \>=50% decrease of target lesions. |
| Secondary | Response of Plexiform Neurofibroma to Neoadjuvant Chemotherapy Using Volumetric MRI Analysis | After 4 Cycles (1 cycle=21 days) | Evaluate the response of plexiformneurofibroma (if present) to neoadjuvant chemotherapy using WHO criteria and volumetric MRI analysis as a tool for response assessment |
| Secondary | Utility of Fludeoxyglucose F18 Positron Emission Tomography (18FDG-PET) and Automated MRI Volumetric Tumor Analysis to Assess Response to Treatment | After 4 cycles | Evaluate the utility of fludeoxyglucose F18 positron emission tomography (18FDG-PET) and automated MRI volumetric tumor analysis as tools to assess response to treatment. |
| Secondary | Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens | After 4 cycles | Correlate response evaluation using WHO, RECIST, 18 FDG-PET and volumetric MRI with percent necrosis in tumor specimens from patients who undergo surgery for local control after chemotherapy. |
| Secondary | Perform Pathologic Analysis of Tumor Samples to Analyze the Number of Participants With Markers as Predictors of Response | After 4 cycles | Evaluate the molecular biology of sporadic and NF1-associated MPNSTs by performing a detailed pathologic analysis of tumor samples with the goal to analyze if markers can be identified that predict for response to chemotherapy or outcome. |
| Secondary | Construct Tissue Microarray to Identify Novel Targets for Treatment for the Number of Participants With Available Tissue | After 4 cycles | Construct a tissue microarray from submitted tumor samples that will be used in the future to identify novel targets for treatment of MPNSTs. The tissue microarray looked at various gene deletions and amplifications. |
| Secondary | Identify the Number of Participants With a Serum Biomarker to Predict the Presence of MPNST Versus Benign Plexiform Neurofibroma | After 4 cycles | Assess if a serum biomarker can be identified that predicts for the presence of a MPNST versus benign plexiform neurofibroma. |
| Secondary | Provide Epidemiology and Clinical Presentation of the Number of Participants With NF1-associated MPNSTs. | After 4 cycles | Increase the knowledge of the epidemiology and clinical presentation of NF1-associated MPNSTs. |
Source ClinicalTrials.gov
Outcomes8
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 Response Rate (Complete Response and Partial Response) | After 4 Cycles (1 cycle=21 days) | 37/48 patients total were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response of Plexiform Neurofibroma to Neoadjuvant Chemotherapy Using Volumetric MRI Analysis | After 4 Cycles (1 cycle=21 days) | MRI imaging of the MPNST and plexiform neurofibroma component was not sufficient to allow for volumetric analysis over time. Reasons include differences in imaging technique over time and incomplete coverage of the entire tumor. | ||
| SECONDARY | Utility of Fludeoxyglucose F18 Positron Emission Tomography (18FDG-PET) and Automated MRI Volumetric Tumor Analysis to Assess Response to Treatment | After 4 cycles | This assessment involved 18FDG-PET and MRI imaging of the MPNST and plexiform neurofibroma component. Due to technical issues with MRI imaging, data was not reliably collected from any study participant to allow for meaningful analysis. | ||
| SECONDARY | Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens | After 4 cycles | 33 patients were evaluable for response after cycle 4, response evaluation using WHO and RECIST was performed. Response evaluation was not assessed with 18 FDG-PET and volumetric MRI. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Perform Pathologic Analysis of Tumor Samples to Analyze the Number of Participants With Markers as Predictors of Response | After 4 cycles | The rows are among three different categories: Histologic Variant, Cellularity and Necrosis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Construct Tissue Microarray to Identify Novel Targets for Treatment for the Number of Participants With Available Tissue | After 4 cycles | The number of participants vary in the rows from overall number analyzed, due to the tissue that was available for testing. | participants | NUMBER |
| SECONDARY | Identify the Number of Participants With a Serum Biomarker to Predict the Presence of MPNST Versus Benign Plexiform Neurofibroma | After 4 cycles | Data looked at response evaluable patients with MPNST and focused on the TOPO2A gene being amplified. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Provide Epidemiology and Clinical Presentation of the Number of Participants With NF1-associated MPNSTs. | After 4 cycles | Clinical evaluation of patients with NF1 was performed at trial enrollment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group68
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 Response Rate (Complete Response and Partial Response) | NF1 MPNST | Partial response | 5 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | Sporadic MPNST | Partial response | 4 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | NF1 MPNST | Complete response | 0 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | Sporadic MPNST | Complete response | 0 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | NF1 MPNST | Stable Disease | 20 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | Sporadic MPNST | Stable Disease | 4 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | NF1 MPNST | Progressive Disease | 3 | Participants | |
| Number of Participants With Response Rate (Complete Response and Partial Response) | Sporadic MPNST | Progressive Disease | 1 | Participants | |
| Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens | NF1 and Sporadic MPNST | Responses in agreement | 29 | Participants | |
| Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens | NF1 and Sporadic MPNST | Responses were not in agreement | 4 | Participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NF1 MPNST | 34 | |
| Overall Study | STARTED | Sporadic MPNST | 14 | |
| Overall Study | Completed 4 Cycles | NF1 MPNST | 22 | |
| Overall Study | Completed 4 Cycles | Sporadic MPNST | 7 | |
| Overall Study | Patients Treated With Surgery | NF1 MPNST | 7 | |
| Overall Study | Patients Treated With Surgery | Sporadic MPNST | 3 | |
| Overall Study | Patients Treated With Surgery and RT | NF1 MPNST | 5 | |
| Overall Study | Patients Treated With Surgery and RT | Sporadic MPNST | 1 | |
| Overall Study | Patients Treated With RT Only | NF1 MPNST | 4 | |
| Overall Study | Patients Treated With RT Only | Sporadic MPNST | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events7
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 | Neurotoxicity | Nervous system disorders | NF1 and Sporadic MPNST | 3 | 48 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | NF1 and Sporadic MPNST | 6 | 48 | |
| serious | Anemia | Blood and lymphatic system disorders | NF1 and Sporadic MPNST | 4 | 48 | |
| serious | Altered mental status | Psychiatric disorders | NF1 and Sporadic MPNST | 1 | 48 | |
| serious | Aphasia | Psychiatric disorders | NF1 and Sporadic MPNST | 1 | 48 | |
| serious | Somnolence | Nervous system disorders | NF1 and Sporadic MPNST | 4 | 48 | |
| serious | Secondary acute myeloid leukemia | Blood and lymphatic system disorders | NF1 and Sporadic MPNST | 1 | 48 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NF1 and Sporadic MPNST | ||
| Total, other adverse events | NF1 and Sporadic MPNST | 3 | 48 |
| Total, serious adverse events | NF1 and Sporadic MPNST | 13 | 48 |
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/NCT00304083
GET https://conductscience.org/api/trials/v1/NCT00304083/results?page=2