Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection
Condition: Neoplasm Metastases
MeSH terms: Neoplasm Metastasis
Intervention: Alpha-Gal Glycosphingolipid
Intervention description: Intra-tumoral injection of Alpha-Gal Glycosphingolipid to evaluate toxicity
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cancerous solid tumors; Alpha-Gal Glycosphingolipids

Summary:

      This is a Phase I pilot study to evaluate the toxicity and feasibility of intratumoral
      injection (Glycosphingolipids) GSL alpha-GAL (beta-galactosidase) in patients with advanced,
      refractory solid tumors who have failed standard therapies or are not eligible for standard
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with solid tumors who have failed standard therapies, or are not candidates
             for standard therapies.

          2. Patients must have at least one measurable lesion that is accessible and suitable for
             injection of the GSL alpha-GAL.

          3. Patients should not be undergoing any active treatment with chemotherapy,
             radiotherapy, or steroids (either because the patient or the treating physician have
             decided not to employ these therapies at this time, or because they had already been
             tried and failed). If they have been treated with these modalities, the treatments
             should have been completed at least two weeks prior to date of injection of GSL
             alpha-GAL.

          4. Patients should be judged by the investigator to be able to undergo safely the
             procedure needed to inject the tumor with GSL alpha-GAL.

          5. Age equal or over 18 years old.

          6. ECOG (Eastern Cooperative Oncology Group ) performance of less than 2. (International
             Normalized Ratio) INR less than 1.5 and a (Partial Thromboplastin Time) PTT no greater
             than normal limits within 1 week prior to intra-tumoral injection (For patients who
             requires invasive procedure for intra-tumoral injection).

          7. Laboratory Criteria (completed equal or less 2 weeks before enrollment) Hematologic:
             (White Blood Cell Count) WBC equal or above 3500/millimeter-cubed or (Absolute
             Neutrophil Count) ANC equal or above 1500/millimeter-cubed and platelet count equal or
             above 100,000/ millimeter-cubed.

             Hepatic: Total bilirubin equal or less 4.0 milligrams/deciliter. Renal: Creatinine
             equal or less 2.2 milligrams/deciliter.

          8. Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating
             antigen), and Hepatitis C (circulating antibody).

          9. Patients should have an expected survival of more than 6 weeks and should not have
             other systemic anti-tumor treatments planned during this time frame.

        Exclusion Criteria:

          1. Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic
             Gonadotropin) in patients of childbearing potential) or nursing.

          2. Patients under the age of 18.

          3. Patients with severe infections or septicemia.

          4. Patients with a history of autoimmune disease.

          5. Patients in, or about to be in, active treatment with chemotherapy or steroids.

          6. Patients who refuse HIV/hepatitis testing and patients who do not sign an approved
             consent form.

          7. Patient has received other investigational drugs within 14 days before enrollment or
             is expected to participate in an experimental drug study during this study treatment.

          8. Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study.