Phase II Study of Trastuzumab (NSC-688097) in Treatment of Locally Advanced or Metastatic Synovial Sarcoma

Histologically confirmed locally advanced or metastatic synovial cell sarcoma. Tumor positive for HER2 (2+ or 3+) by immunohistochemistry using an FDA-approved antibody. Tumor tissue available and willing to allow submission. Must be offered the opportunity to consent for banking. Measurable disease. Measurable disease assessed within 28 days prior to reg. Non-measurable disease assessed within 42 days prior to reg. Should have received at least one chemo regimen prior to reg. (If refusal to receive chemotherapy can be documented, patient is eligible.) Three weeks elapsed since prior chemo. Not planning to receive concomitant RT. If prior RT, embolization or RFA to target lesion, at least 60 days elapsed since completion of therapy and lesion demonstrated progression following completion. At least 21 days elapsed since prior major surgery and recovered from all effects. Within 14 days prior to reg: serum bilirubin < 1.5 x IULN; SGOT and/or SGPT < 1.5 x IULN (< 5 x IULN if liver metastases); serum creatinine < 1.5 x IULN or creatinine clearance > 60 ml/min; ANC > 1,000/mcl; hemoglobin > 8 gm/dL; platelets > 100,000/mcl. LVEF > 45% by MUGA within 28 days prior to reg. At least 18 years of age. Zubrod performance status less than or equal to 2. No active peptic ulcer, active GI bleeding or active inflammatory disease of bowel. No known CNS metastases. Not pregnant or nursing. If of reproductive potential, agree to use effective contraceptive method. No other prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which patient is currently in complete remission, or any other cancer from which patient has been disease-free for 5 years.