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.