Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Ner… (NCT00304083) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
United States48 participantsStarted 2005-12
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Response Rate (Complete Response and Partial Response)
Timeframe: After 4 Cycles (1 cycle=21 days)
Trial details
NCT IDNCT00304083
SponsorSarcoma Alliance for Research through Collaboration