Evaluate The Toxicity And Feasibility Of Intra-Tumoral Injection

Completed · Phase 1

Conditions studied: Neoplasm Metastases

In brief

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.

Key facts

Study ID

NCT00668382

Run by

University of Massachusetts, Worcester

People needed

11

Starts

2007-07-01

Expected to finish

2011-07-01

Last updated by the study team

2013-05-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with solid tumors who have failed standard therapies, or are not candidates for standard therapies.
• Patients must have at least one measurable lesion that is accessible and suitable for injection of the GSL alpha-GAL.
• 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.
• Patients should be judged by the investigator to be able to undergo safely the procedure needed to inject the tumor with GSL alpha-GAL.
• Age equal or over 18 years old.
• 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).
• 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.
• Patients must be negative for HIV (circulating antibody), Hepatitis B (circulating antigen), and Hepatitis C (circulating antibody).
• 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.

You may not qualify if…

• Patients who are pregnant (as determined by a positive serum HCG (Human Chorionic Gonadotropin) in patients of childbearing potential) or nursing.
• Patients under the age of 18.
• Patients with severe infections or septicemia.
• Patients with a history of autoimmune disease.
• Patients in, or about to be in, active treatment with chemotherapy or steroids.
• Patients who refuse HIV/hepatitis testing and patients who do not sign an approved consent form.
• 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.
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Where it is running

• University of Massachusetts Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.