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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, multi-center study of GM-CT-01, which has been shown to increase the anti-tumor activity of 5-fluorouracil in mice. The primary reason for doing the study is to determine the safety of GM-CT-01 given alone and in combination with therapeutical dosage of 5-Fluorouracil, in patients who have advanced cancer that can be measured by CT scan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galectin Therapeutics Inc.
• Treatments: Fluorouracil

Criteria

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.