A Phase I Surrogate Endpoint Trial of Human Recombinant Endostatin in Patients With Advanced Solid Tumors Amenable to Biopsy

Date de début de l'étude : 1 octobre 1999

DISEASE CHARACTERISTICS: Histologically proven advanced solid tumor for which no standard curative therapy exists Must be amenable to biopsy At least 1 site of measurable disease outside of irradiated field No brain metastases by CT or MRI scan PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 WBC greater than 3,000/mm3 Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Bilirubin less than 1.5 times upper limit of normal (ULN) ALT and AST less than 2.0 times ULN PT/PTT less than 1.5 times ULN Creatinine less than 1.5 mg/dL OR creatinine clearance greater than 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No concurrent uncontrolled medical or psychiatric disorder No history of bleeding diathesis PRIOR CONCURRENT THERAPY: No concurrent over the counter biologic agents (e.g., shark cartilage) At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) No more than 3 prior chemotherapy regimens for metastatic or recurrent disease (ECOG 1) Prior adjuvant chemotherapy for nonmetastatic disease allowed Concurrent stable dose of hormone replacement therapy allowed At least 3 weeks since prior radiotherapy No concurrent radiotherapy At least 24 hours since minor surgery (e.g., central venous placement) At least 4 weeks since major surgery (e.g., laparotomy, thoracotomy, or craniotomy) At least 30 days since other prior investigational agents No concurrent herbal remedies No concurrent usage of products containing heparin No other concurrent anticancer therapy Concurrent multivitamins allowed