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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00054977
First received: February 14, 2003
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Colorectal Cancer
Lung Cancer
Breast Cancer
Head and Neck Cancer
Prostate Cancer
Drug: GM-CT-01
Drug: 5-fluorouracil
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Galectin Therapeutics Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 60 days - two cycles of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor progression [ Time Frame: CT imaging at 60 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: February 2003
Study Completion Date: September 2006
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054977

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

No publications provided

Responsible Party: Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00054977     History of Changes
Other Study ID Numbers: DAVFU-001
Study First Received: February 14, 2003
Last Updated: March 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Galectin Therapeutics Inc.:
cancer
tumor

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on September 11, 2014