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

NCT00054977 | Completed Phase 1

• 1 other identifier: DAVFU-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Lung Cancer; Breast Cancer; Head and Neck Cancer; Prostate Cancer

Keywords

cancer; tumor

Outcome Measures

Primary Outcomes (1)

• Safety

  60 days - two cycles of treatment

Secondary Outcomes (1)

• Tumor progression

  CT imaging at 60 days

Interventions

GM-CT-01 DRUG

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.

Also known as: DAVANAT

5-fluorouracil DRUG

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.

Also known as: 5-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (4)

Florida Oncology Associates

Jacksonville, Florida, 32207, United States

Location

Ochsner Cancer Institute

New Orleans, Louisiana, 70121, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Prostatic Neoplasms; Neoplasms

Interventions

galactomannan; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marilyn C Pike, M.D., Ph.D.

  Consultant to Pro-Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2003
• First Posted: February 17, 2003
• Study Start: February 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: September 1, 2006
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

US (4)