Safety of GM-CT-01 With and Without 5-Fluorouracil in Patients With Solid Tumors

Inclusion Criteria: * The subject is able to give informed consent to participate in this trial (including all procedures and follow-up visits). * The subject is male or female at least 18 years of age. * The subject has a documented histologic or cytologic recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value. * Subjects must have completed previous therapy (chemotherapeutic agents or other therapies including radiation) at least 4 weeks prior to study entry. * Following major surgery (e.g. laparotomy), \> 4 weeks must have elapsed and subjects must have recovered from effects. * Following minor surgery (does not include insertion of vascular access device), \> 2 weeks must have elapsed. * ECOG performance status of 0-2. * The subject has a life expectancy of at least 12 weeks. * Female subjects must be post-menopausal, surgically sterile, or using effective contraception. Laboratory values prior to administration of study drug: * If female and not post-menopausal, the subject has a negative pregnancy test. * Liver function studies: AST and ALT \< 2.5 times the upper limit of normal (ULN); total bilirubin \< 1.5 * Hematopoietic parameters: WBC \> 3000 per mm3; Granulocyte count \> 1,500 per mm3; Platelet count \> 100,000 per mm3 * Renal: Creatinine \< or = ULN * Pulmonary: Dlco \> or = 60% of predicted Exclusion Criteria: * If female, the subject is pregnant or breast feeding. * Central nervous system (CNS) metastases or primary CNS tumors. * The subject has a known hypersensitivity to GM-CT-01 or any of its components. * The subject has congestive heart failure or any other medical condition that could be adversely affected by intravenous infusion of up to approximately 200 mL of fluid over 60 minutes. * The subject is currently abusing alcohol and/or illicit drugs. * The subject has other significant medical, psychiatric, or social conditions which, in the investigators' opinion, may compromise the subject's safety in participating in this study. * In the investigators' judgment, the subject would be unreliable in adhering to the study visit schedule or other study requirements. * The subject is currently enrolled in a clinical trial or has participated in a clinical trial within the 30 days prior to entry into this study.