Study to Determine Maximum Tolerated Dose of LErafAON Combined With Radiotherapy in Patients With Advanced Malignancies

You may be eligible if

• Disease Characteristics-
• Histologically-confirmed malignancy which has recurred or progressed after initial definitive treatment and/or for which no curative therapy is available.
• Palliative radiation therapy indicated for disease and site. (More than one lesion may be treated with radiation therapy.)
• At least 30 days must have elapsed since receiving an investigational agent, at least 21 days since receiving any prior chemotherapy or radiation, and at least six weeks since receiving nitrosourea-containing therapy; patient must have recovered from any related side effects.
• The site for radiotherapy, the index lesion, must have a measurable or evaluable tumor documented no more than 4 weeks prior to having study-related procedures. More than one lesion may be present and treated with radiotherapy. Additional lesions, not treated with radiotherapy, may also be present. Previously irradiated sites will NOT be irradiated in this study.
• Patient Characteristics-
• Performance Status (ECOG/ZUBROD) of 0-2.
• Must be at least 18 years of age.
• Must have adequate organ function: Absolute neutrophil count at least 1,500/mm3; Platelets at least 100,000/mm3; Creatinine, Calcium, and total Bilirubin not higher than the upper limit of normal; Liver enzymes AST and ALT not more than 2.5 x the upper limit of normal; PT and aPTT not more than the upper limit of normal.
• Life expectancy more than 12 weeks.
• Must sign Informed Consent.
• Planned treatment site(s) has not had previous radiation therapy.
• Patients must not have concurrent antitumor therapy other than that planned in the study.
• No history of Grade 4 toxicity from prior radiation therapy. (Grade 3 toxicity from prior radiation therapy, at investigator discretion.)
• No infection requiring parenteral antibiotics; no HIV infection; no chronic hepatic disease; and no seropositivity for Hepatitis B and Hepatitis C. (Use of prophylactic antibiotics is permitted.)
• No pregnant or lactating females. All females of child-bearing potential must use an effective method of contraception.
• No active central nervous system (CNS) metastasis. Neuroimaging is required only if metastasis is suggested by history or physical examination.