Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00304083
• Date of registration: 15/03/2006
• Prospective Registration: No
• Primary sponsor: Sarcoma Alliance for Research through Collaboration
• Public title: Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
• Scientific title: Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors
• Date of first enrolment: December 2005
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00304083
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Brigitte C. Widemann, MD
• Affiliation: National Cancer Institute (NCI)

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Newly diagnosed sporadic or neurofibromatosis type 1 (NF1)-associated high-grade
malignant peripheral nerve sheath tumors (MPNSTs)

- Stage III or stage IV (metastatic) disease

- Measurable disease, defined as at least 1 tumor that is measurable in 2 dimensions on
CT scan or MRI

PATIENT CHARACTERISTICS:

- Ejection fraction normal by echocardiogram or MUGA

- Serum creatinine normal for age OR creatinine clearance > 60 mL/min

- SGPT < 5 times upper limit of normal (ULN)

- Bilirubin < 2.5 times ULN

- Absolute neutrophil count = 1,500/mm^3*

- Hemoglobin = 9.0 g/dL*

- Platelet count = 100,000/mm^3*

- ECOG performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment NOTE: * Unsupported

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy for MPNST

- Prior surgical resection of MPNST allowed provided residual or recurrent measurable
disease is present

- Recovered from toxic effects of all prior therapy

- At least 3 weeks since prior chemotherapy or biologic therapy for treatment of a
plexiform neurofibroma, optical pathway tumor, or other NF1-associated tumor (in
patients with NF1)

- At least 6 weeks since prior radiotherapy for treatment of a plexiform neurofibroma,
optical pathway tumor, or other NF1-associated tumor (in patients with NF1)

- At least 4 weeks since prior radiotherapy to the area involved by MPNST

- No other concurrent growth factors (e.g., sargramostim [GM-CSF] or interleukin-11)

- Concurrent epoetin alfa allowed



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoma

Neurofibromatosis Type 1

Intervention(s)

Drug: ifosfamide

Procedure: conventional surgery

Drug: etoposide

Radiation: radiation therapy

Biological: filgrastim

Drug: doxorubicin hydrochloride

Primary Outcome(s)

Number of Participants With Response Rate (Complete Response and Partial Response) [Time Frame: After 4 Cycles (1 cycle=21 days)]

Secondary Outcome(s)

Construct Tissue Microarray to Identify Novel Targets for Treatment for the Number of Participants With Available Tissue [Time Frame: After 4 cycles]

Provide Epidemiology and Clinical Presentation of the Number of Participants With NF1-associated MPNSTs. [Time Frame: After 4 cycles]

Perform Pathologic Analysis of Tumor Samples to Analyze the Number of Participants With Markers as Predictors of Response [Time Frame: After 4 cycles]

Utility of Fludeoxyglucose F18 Positron Emission Tomography (18FDG-PET) and Automated MRI Volumetric Tumor Analysis to Assess Response to Treatment [Time Frame: After 4 cycles]

Response Evaluation Using WHO, RECIST, 18 FDG-PET and Volumetric MRI With Percent Necrosis in Tumor Specimens [Time Frame: After 4 cycles]

Identify the Number of Participants With a Serum Biomarker to Predict the Presence of MPNST Versus Benign Plexiform Neurofibroma [Time Frame: After 4 cycles]

Response of Plexiform Neurofibroma to Neoadjuvant Chemotherapy Using Volumetric MRI Analysis [Time Frame: After 4 Cycles (1 cycle=21 days)]

Secondary ID(s)

SARC006

NCI-06-C-0043

NCI-P6452

UMN-2007CG077

SARC-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Results

• Results available: Yes
• Date Posted: 25/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00304083