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TLR8 Agonist VTX-2337 in Combo With Local Radiation in Low-Grade B-cell Lymphomas
This study is currently recruiting participants.
Verified July 2011 by Stanford University

First Received on July 6, 2011.   Last Updated on July 14, 2011   History of Changes
Sponsor: Stanford University
Collaborator: VentiRx Pharmaceuticals Inc.
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT01396018
  Purpose

The primary objective is to determine the local and systemic anti-tumor effects of intratumoral injection of VTX-2337, a TLR8 agonist, in combination with low-dose local radiation at a single tumor site, in patients with recurrent b-cell lymphoma.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Cutaneous Lymphoma
Large B Cell Diffuse Lymphoma
Mantle Cell Lymphoma
Marginal Zone B-Cell Lymphoma
Peripheral T-cell Lymphoma, Large Cell
Waldenstrom Macroglobulinemia
Procedure: CT Scan
Procedure: local radiotherapy
Drug: VTX-2337
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Intratumoral Injection of the Small Molecule TLR8 Agonist VTX-2337 in Combination With Local Radiation in Low-Grade B-cell Lymphomas

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Overall objective response rate at time of best response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported and clinical observation of adverse events, including changes in physical examination, peripheral blood hematology and serum chemistry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: May 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CT Scan
    Standard of Care
    Other Name: X-ray computed tomography
    Procedure: local radiotherapy
    Standard of Care
    Other Name: Radiation Therapy
    Drug: VTX-2337
    3.0 mg/m2 per injection
    Other Name: VentiRx, Pharmaceuticals, Inc.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient must meet all of the following criteria in order to be enrolled:

  1. Biopsy-confirmed low-grade B-cell lymphoma; specifically, follicular grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma, of any initial stage. Patients must be relapsed from prior therapy
  2. Patients must have one site of disease that is accessible for intratumoral injection of VTX-2337 percutaneously
  3. Tumor specimens must be available for immunological studies, either from a previous biopsy or a new biopsy obtained before Day 1 of the study. If applicable, the new biopsy must be obtained from a site of disease other than the intended injection site.
  4. Patients must have measurable disease other than the injection site or biopsy site
  5. ECOG Performance Status of 1 or better (corresponds to Karnofsky Performance Status (KPS) of >= 70)
  6. Patients must be 18 years of age or older.
  7. Adequate bone marrow function: WBC >= 2,000/uL; platelet count >= 75,000/mm^3; ANC >= 1000/uL.
  8. Adequate renal function: serum creatinine < 2.0mg/dL
  9. Adequate hepatic function: bilirubin < 1.5 mg/dL; SGOT/SGPT < 3 x upper limit of normal
  10. Required wash out periods for prior therapy:

    • Topical therapy: 2 weeks
    • Chemotherapy: 4 weeks
    • Radiotherapy: 4 weeks
    • Other investigational therapy: 4 weeks
    • Rituximab: 12 weeks
  11. Patients of reproductive potential and their partners must agree to use an effective (> 90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration.
  12. Women of reproductive potential must have negative urine pregnancy test.
  13. Life expectancy greater than 4 months.
  14. Able to comply with the treatment schedule.
  15. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient may not be enrolled in the trial if any of the following criteria are met:

  1. Pre-existing autoimmune or antibody-mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, history of uveitis. Patients with controlled thyroid disease, or the presence of auto-antibodies without clinical autoimmune disease, are permitted on study
  2. Known history of human immunodeficiency virus (HIV)
  3. Patients with active infection or with a fever > 38.5°C within three days prior to the first scheduled treatment.
  4. Known CNS metastases
  5. Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix
  6. History of allergic reactions attributed to compounds of similar composition to VTX-2337
  7. Current anticoagulant therapy. (ASA <= 325 mg per day is allowed.)
  8. Significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
  9. Pregnant or lactating
  10. Any other medical history, including laboratory abnormalities, deemed by the Investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396018

Contacts
Contact: Lori Richards (650) 725-4968 lorir@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lori Richards     650-725-4968     lorir@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061     ccto-office@stanford.edu    
Principal Investigator: Ronald Levy            
Sub-Investigator: Joshua Brody            
Sponsors and Collaborators
Stanford University
VentiRx Pharmaceuticals Inc.
Investigators
Principal Investigator: Ronald Levy Stanford University
  More Information

No publications provided

Responsible Party: Ronald Levy, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01396018     History of Changes
Other Study ID Numbers: SU-04262011-7706, LYMNHL0086
Study First Received: July 6, 2011
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Waldenstrom Macroglobulinemia
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 14, 2012