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Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (HCT)

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ClinicalTrials.gov Identifier: NCT01745354
Recruitment Status : Terminated (Accrual issues - Slow accrual)
First Posted : December 10, 2012
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Robert Lowsky, Stanford University

Brief Summary:
For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using cells from a healthy donor represents potentially curative treatment. In these individuals, cure is possible because transplantation of healthy donor immune cells can fight the lymphoma in the patient. The goal of this work is to test a strategy that activates the healthy donor immune cells so that they more effectively fight lymphoma and can result in an increased cure rate for these patients. Our group has previously studied CpG, an immune activating medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now have a more potent form of CpG which we intend to test to see if it will better activate the donor immune cells and result in shrinkage of tumor throughout the entire body, not just at the injected site.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Hodgkin Disease Drug: SD-101 Radiation: Local Radiation Phase 1

Detailed Description:
Patients will receive low dose radiation to all bulky or symptomatic lymph nodes on days -2 and -1. SD-101 will be administered intratumorally to the single largest palpable node within 24 hours after completion of radiation, on day 0. Two additional intratumoral SD-101 injections will be performed on days 7 (+/- 2 days) and 14 (+/- 2 days). This is a dose ranging study using a 3+3 design with a definition of maximum tolerated dose (MTD) which our group has found acceptable in the past. The first cohort of patients will receive a SD-101 dose of 0.3 mg per injection. The dose will be escalated to 1 mg and 3 mg based on dose limiting toxicity (DLT).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intratumoral Injection of an Immunostimulatory CpG, SD-101, Combined With Local Radiation for the Treatment of Recurrent or Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation
Study Start Date : August 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: SD-101 + Combined with Local Radiation Drug: SD-101
SD-101 will be administered after radiation to only the largest palpable lymph node as an intratumoral injection weekly for 3 weeks at three dosing cohorts: 0.3 mg, 1 mg, and 3 mg
Other Name: Dynavax

Radiation: Local Radiation

Primary Outcome Measures :
  1. Determination of the maximum tolerated dose based on dose limiting toxicity defined as any new grade 3-4 toxicity after the first SD-101 administration [ Time Frame: 60 Days ]

Secondary Outcome Measures :
  1. Measure cytotoxic T-cell activity changes pre- and post-treatment of tumor infiltrating lymphocytes and peripheral blood lymphocytes using ELISA and Immunohistochemistry. [ Time Frame: 2, 3, 8 weeks after treatment ]
  2. Measure tumor response by PET-CT scan imaging [ Time Frame: 8 weeks after treatment ]
  3. Measure level of donor specific tumor infiltrating lymphocytes by flow cytometry and Immunofluorescence [ Time Frame: 2, 3, 8 weeks after treatment ]
    Collect PBMCs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section 3.2.1 for excluded subtypes)
  • At least 3 sites of disease

    1. One for diagnosis (lymph node or bone marrow biopsy)
    2. One palpable for treatment
    3. One measurable radiographically
  • > 60 days after RIC allogeneic transplant for lymphoma
  • 18 years of age or older
  • Mixed (5-95%) or complete (>95%) chimerism
  • Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2
  • ANC >1000/mm3, platelets >50,000/mm3
  • Total bilirubin ≤ 2.5 mg/dL, AST and ALT < 3 times upper limit of normal
  • Serum creatinine ≤ 3 mg/dL
  • No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment
  • Minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤ 200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment

Exclusion Criteria:

  • HIV associated lymphoma
  • Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)
  • Active infection within 14 days prior to scheduled treatment
  • Active Cytomegalovirus (CMV) disease at the time of enrollment
  • Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745354

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United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Robert Lowsky
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Principal Investigator: Robert Lowsky Stanford University
Principal Investigator: Lauren Maeda Stanford University
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Responsible Party: Robert Lowsky, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01745354    
Other Study ID Numbers: BMT235
SU-07212011-8129 ( Other Identifier: Stanford University )
20741 ( Other Identifier: stanford IRB )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2015
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases