A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

Date de début de l'étude : 22 février 1999

DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced solid tumor unresponsive to existing therapy or for which no curative therapy exists Evidence of disease in addition to tumor marker elevation CNS metastases allowed, if adequately treated and symptoms controlled for greater than 4 months PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 PTT normal Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGOT or SGPT no greater than 3 times ULN (4 times ULN for liver metastases) Renal: Creatinine no greater than 1.25 times ULN Proteinuria less than 2+ (no greater than 500 mg in a 24 hour urinalysis) Other: No active infection No other serious systemic disease No known hypersensitivity to oligodeoxynucleotides Adequate venous access No known condition (e.g., psychological, geographical) that would prevent compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after the study PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors unless evidence of neutropenic infection Chemotherapy: No more than 3 prior chemotherapy regimens At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support No concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent palliative radiotherapy allowed Surgery: At least 2 weeks since prior major surgery Other: At least 3 weeks since prior investigational drug therapy No other concurrent investigational drug or anticancer therapy No concurrent coumadin or heparin therapy