Patient case: 26-year-old male with Liposarcoma. Genetic variant: MDM2 Amplification. Other conditions: None.

Clinical trial: Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
  PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

Detailed description: OBJECTIVES:
  -  Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
  -  Determine the safety of this drug in these patients.
  OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).
  Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.
  PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed soft tissue sarcoma
  -  Malignant fibrous histiocytoma
  -  Liposarcoma
  -  Rhabdomyosarcoma
  -  Synovial sarcoma
  -  Malignant paraganglioma
  -  Fibrosarcoma
  -  Leiomyosarcoma
  -  Angiosarcoma including hemangiopericytoma
  -  Malignant peripheral nerve sheath tumor
  -  Unclassified sarcoma
  -  Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  -  The following tumor types are excluded:
  -  Gastrointestinal stromal tumor
  -  Chondrosarcoma
  -  Malignant mesothelioma
  -  Neuroblastoma
  -  Osteosarcoma
  -  Ewing's sarcoma
  -  Embryonal rhabdomyosarcoma
  -  Prior chemotherapy for metastatic disease required
  -  One line of combination chemotherapy containing anthracycline OR
  -  No more than 2 single-agent regimens including anthracycline
  -  Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
  -  Must have 1 measurable lesion
  -  Clinical evidence of progression within 6 weeks prior to study
  -  Osseous lesions and pleural effusions not considered measurable
  -  No known or symptomatic CNS metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  15 to 75
  Performance status:
  -  WHO 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 4,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.8 mg/dL
  -  Albumin at least 2.5 g/dL
  Renal:
  -  Creatinine no greater than 1.4 mg/dL OR
  -  Creatinine clearance greater than 65 mL/min
  Cardiovascular:
  -  No history of severe cardiovascular disease
  Other:
  -  Not pregnant
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for up to 6 months after study participation
  -  No other severe medical illness, including psychosis
  -  No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  More than 4 weeks since prior chemotherapy
  -  No other concurrent cytotoxic therapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No radiotherapy to the sole measurable lesion
  -  No concurrent radiotherapy
  Surgery:
  -  Not specified
  Other:
  -  No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
  -  No other concurrent anticancer therapy

Relevance to patient case: not relevant