Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.
  -  Assess local-regional control in patients treated with this regimen.
  -  Determine the disease-free survival of patients treated with this regimen.
  -  Determine the pathologic response in patients treated with this regimen.
  -  Determine the toxic effects of this regimen in these patients.
  -  Determine the complications in patients treated with this regimen.
  OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.
  Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed primary or recurrent soft tissue sarcoma of the retroperitoneum or pelvis
  -  No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumor, osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or aggressive fibromatosis
  -  No sarcoma that does not allow sparing of two-thirds of 1 kidney within planned irradiation field
  -  Radiographically measurable disease greater than 5 cm (T2) by CT scan or MRI of the abdomen and pelvis
  -  High-grade (grade 3/3, 3/4, 4/4) disease greater than 5 cm OR
  -  Moderate-grade (grade 2/3, 2/4) recurrent disease greater than 10 cm
  -  Eligible for gross total resection (R0 or R1)
  -  No prior subtotal (R2) resection
  -  Partial debulking OR subtotal tumor resection with residual gross disease
  -  Fewer than 4 equivocal pulmonary lesions each less than 3 mm in diameter by CT scan
  -  No multifocal disease suggestive of regional nodal involvement
  -  No metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Zubrod 0-2
  Life expectancy:
  -  At least 2 years
  Hematopoietic:
  -  Absolute neutrophil count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.5 mg/dL
  -  AST no greater than 3 times upper limit of normal
  -  Albumin at least 3.5 g/dL
  Renal:
  -  Creatinine no greater than 1.6 mg/dL
  -  Two functional kidneys
  Cardiovascular:
  -  No congestive heart failure
  -  No myocardial infarction within the past 6 months
  -  No New York Heart Association class III or IV heart disease
  -  Ejection fraction at least 50%
  Other:
  -  No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  -  No serious medical or psychiatric illness that would preclude study entry
  -  No obvious bowel obstruction
  -  No hypersensitivity to E. coli-derived products
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Oral caloric intake at least 1,500 kCal/day
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior doxorubicin or ifosfamide
  -  No prior chemotherapy for sarcoma
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior abdominal or pelvic irradiation
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant