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Intratumoral Injection Of Alpha-Gal Glycosphingolipids

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ClinicalTrials.gov Identifier: NCT00668512
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : March 19, 2015
Information provided by (Responsible Party):
Giles Whalen, University of Massachusetts, Worcester

April 25, 2008
April 29, 2008
March 19, 2015
March 2007
March 2014   (Final data collection date for primary outcome measure)
Grade 3/4 toxicity [ Time Frame: 11-12 weeks ]
Grade 3/4 toxicity or adverse event during injection protocol or up to a month after
Destruction of visible metastases, and Induction of an immune response that will destroy invisible micrometastases. [ Time Frame: 11-12 weeks ]
Complete list of historical versions of study NCT00668512 on ClinicalTrials.gov Archive Site
Clinical response [ Time Frame: 2 years ]
Injected tumor deposit regression (RECIST), regression of other known metastases (RECIST), progression of disease (new metastases)
Not Provided
Immune response in injected lesion [ Time Frame: six weeks ]
Evidence of immune cell infiltration of injected tumor: histologic comparison of biopsy of injected lesion with pre injection biopsy of same lesion
Not Provided
Intratumoral Injection Of Alpha-Gal Glycosphingolipids
Phase I Study To Evaluate The Toxicity And Feasibility Of Intratumoral Injection Of Alpha-Gal (Beta-galactosidase ) Glycosphingolipids In Patients With Advanced Melanoma
This is a Phase I pilot study to evaluate the toxicity of two intra-tumoral injections of GSL alpha-GAL in patients with advanced or metastatic cutaneous melanoma. Patients who have failed standard therapies or are not eligible for standard treatment will be eligible for this study.

A standard Phase I dose escalation model will be used to define the maximum tolerated dose (MTD) of GSL alpha-GAL that can be administered directly into the tumor lesion on two separate injections separated by 4-weeks. This trial will serve as the basis for future Phase II trials utilizing multiple injections of GSL alpha-GAL in refractory solid tumors.

Additionally, in this study we will look for histologic evidence of an immune response against the injected melanoma lesions which matches that seen in mice. Our hypothesis for this study is that a second injection of GSL alpha-GAL into a melanoma lesion will not precipitate an allergic or autoimmune reaction, but will cause a histologically evident immune response to the tumor.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Metastatic Melanoma
Biological: Antimelanoma injection of GSL alpha-Gal
Single arm, phase 1 trial of escalating doses of GSL alpha-Gal (0.1mg, 1mg, 10mg)injected into a melanoma metastasis at day 0 and then again 4 weeks later.
Other Name: Alph-Gal Glycosphingolipids
Experimental: Antimelanoma injection-GSL alpha-Gal
Intervention consists of injection of a single melanoma metastasis with two injections of GSL alpha-Gal separated by four weeks. Both injections done with the same dose of GSL alpha-GAL each time. Phase 1 dose escalating scheme: 0.1mg, 1 mg, 10mg
Intervention: Biological: Antimelanoma injection of GSL alpha-Gal

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with recurrent melanoma who have failed standard therapies, or are not candidates for standard therapies.
  2. Patients must have at least one measurable cutaneous 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 has 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 >18 years old.
  6. ECOG (Eastern Cooperative Oncology Group) performance of <2. International Normalized Ratio (INR)<1.5 and a PTT (partial thromboplastin time ) no greater than normal limits within 1 week prior to intra-tumoral injection (For patients who may be on blood thinners)
  7. Laboratory Criteria (completed <2 weeks before enrollment) Hematologic: (White Blood Cell Count) WBC > 3500/mm3 or (absolute neutrophil count) ANC > 1500/mm3 and platelet count > 100 000/ mm3 Hepatic: Total bilirubin < 4.0 mg/dl Renal: Creatinine < 2.2 mg/dl.
  8. Patients must be negative for HIV (circulating antibody), Hepatitis B (circulatory antigen), and Hepatitis C (circulating antibody).
  9. Patients should have an expected survival of >6 weeks and should not have other systemic anti-tumor treatments planned during this time frame.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not eligible:

  1. Patients who are pregnant or nursing (PRN serum pregnancy test to be done at week -1).
  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 experiment drug study during this study treatment.
  8. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Giles Whalen, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Giles Whalen, MD University of Massachusetts, Worcester
University of Massachusetts, Worcester
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP