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A Phase I/II Study of Intratumoral Injection of SD-101, an Immunostimulatory CpG, and Intratumoral Injection of Ipilimumab, an Anti-CTLA4 Monoclonal Antibody, in Combination With Local Radiation in Low-Grade B-Cell Lymphomas

This phase I/II trial studies the side effects and best dose of ipilimumab in combination with toll-like receptor 9 (TLR9) agonist SD-101 and radiation therapy in treating patients with low-grade B-cell lymphoma that has returned. Monoclonal antibodies, such as ipilimumab, may block cancer growth in different ways by targeting certain cells. Biological therapies, such as TLR9 agonist SD-101, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving ipilimumab in combination with TLR9 agonist SD-101 and radiation therapy may be a better treatment for B-cell lymphoma.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : ipilimumab
  • drug : TLR9 agonist SD-101
  • other : laboratory biomarker analysis
  • radiation : radiation therapy

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Biopsy confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, or 3A marginal zone or small lymphocytic lymphoma; patients must have relapsed from or are refractory to prior therapy - Patients must have at least one site of disease that is accessible for intratumoral injection of SD-101 and of ipilimumab (diameter >= 10mm), percutaneously - Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study - Patients must have measurable disease other than the injection site or biopsy site - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (corresponds to Karnofsky performance status [KPS of >= 70) - White blood cell count (WBC): >= 2000/ÁL (~2 x 10^9/L) - Absolute neutrophil count (ANC): >= 1000/ÁL (~0.5 x 10^9/L) - Platelets: >= 75 x 10^3/ÁL (~75 x 10^9/L) - Hemoglobin: >= 8 g/dL (may be transfused) - Creatinine: =< 2.0 x upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): =< 2.5 x ULN for subjects without liver metastasis; =< 5 times for liver metastases - Bilirubin: =< 2.0 x ULN (except for subjects with Gilbert's Syndrome, who must have a total bilirubin of less than 3.0 mg/dL) - No active or chronic infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C - Must be at least 4 weeks since treatment with standard or investigational chemotherapy, biochemotherapy, surgery, radiation, cytokine therapy, and 8 weeks since any monoclonal antibodies or immunotherapy, and recovered from any clinically significant toxicity experienced during treatment - Patients of reproductive potential must agree to use an effective (> 90% reliability) form of contraception during the study and for 6 months following the last study drug administration - Women of reproductive potential must have negative urine pregnancy test - Life expectancy greater than 4 months - Able to comply with the treatment schedule - Ability to understand and the willingness to sign a written informed consent document

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

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