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

• ClinicalTrials.gov Identifier: NCT00054977
• Recruitment Status: Completed
• First Posted: February 17, 2003
• Last Update Posted: March 12, 2012
• Sponsor: Galectin Therapeutics Inc.
• Information provided by (Responsible Party): Galectin Therapeutics Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Lung Cancer; Breast Cancer; Head and Neck Cancer; Prostate Cancer	Drug: GM-CT-01; Drug: 5-fluorouracil	Phase 1

Detailed Description:

5-Fluorouracil is a chemotherapy drug commonly used in cancer patients. Patients with different type of solid tumors who have failed standard, approved treatments can be enrolled in the study. Escalated doses of GM-CT-01 will be given alone in Cycle 1, and in combination with 5-fluorouracil in cycle 2. Patients will be on study for approximately 60 days for determination of safety. However, with patient consent treatment can continue until disease progression is determined by CT scan. The study secondary reason is to determine whether treatment has stabilize the tumors or change it in size (get bigger, smaller or stay the same)after Cycle 2 and any additional cycles of treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Open-Label Study to Evaluate the Safety and Tolerability of Escalating Doses of GM-CT-01 in the Presence and Absence of 5-Fluorouracil (5-FU) in Subjects With Advanced Solid Tumors
• Study Start Date: February 2003
• Actual Primary Completion Date: April 2005
• Actual Study Completion Date: September 2006

Arms and Interventions

Intervention Details:

• Drug: GM-CT-01
  IV infusion over 30 minutes of 6 Dosages escalated from 30 to 280 mg/m2, given for 4 consecutive days in a 28 days cycle.
  Other Name: DAVANAT
• Drug: 5-fluorouracil
  IV infusion over 30 minutes at Dosage of 500 mg/m2, given in-combination with GM-CT-01, for 4 consecutive days in a 28 days cycle.
  Other Name: 5-FU

Outcome Measures

Primary Outcome Measures :

1. Safety [ Time Frame: 60 days - two cycles of treatment ]

Secondary Outcome Measures :

1. Tumor progression [ Time Frame: CT imaging at 60 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Florida Oncology Associates

Jacksonville, Florida, United States, 32207

United States, Louisiana

Ochsner Cancer Institute

New Orleans, Louisiana, United States, 70121

United States, Michigan

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Galectin Therapeutics Inc.

Investigators

• Study Director: Marilyn C Pike, M.D., Ph.D.; Consultant to Pro-Pharmaceuticals, Inc.

More Information

• Responsible Party: Galectin Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00054977 History of Changes
• Other Study ID Numbers: DAVFU-001
• First Posted: February 17, 2003
• Last Update Posted: March 12, 2012
• Last Verified: March 2012

Keywords provided by Galectin Therapeutics Inc.:

cancer; tumor

Additional relevant MeSH terms:

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Fluorouracil; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs