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Sarcoma

Combination Chemotherapy for Stage III-IV Malignant Peripheral Nerve Sheath Tumors (7007)
Phase II Trial of Chemotherapy in Sporadic and Neurofibromatosis Type 1 Associated High Grade Malignant Peripheral Nerve Sheath Tumors
Status Conditions Phase Study ID
Closed Neurofibromatosis Type 1
Sarcoma
Phase II 7007
NCT00304083
Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with stage III or stage IV malignant peripheral nerve sheath tumors.


Investigator
Robin L. Jones, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

 

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Last Updated
August 20, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.