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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

Phase 1
18 Years
Not Enrolling
Colorectal Cancer, Lung Cancer, Breast Cancer, Head and Neck Cancer, Prostate Cancer

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

60 days - two cycles of treatment

Safety Issue:


Principal Investigator

Marilyn C Pike, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Consultant to Pro-Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2003

Completion Date:

September 2006

Related Keywords:

  • Colorectal Cancer
  • Lung Cancer
  • Breast Cancer
  • Head and Neck Cancer
  • Prostate Cancer
  • cancer
  • tumor
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Ochsner Cancer Institute New Orleans, Louisiana  70121
Florida Oncology Associates Orange Park, Florida  32073