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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Non-Hodgkin, Hodgkin Disease

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Trial Information

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


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).


Inclusion Criteria:



1. Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section
3.2.1 for excluded subtypes)

2. At least 3 sites of disease

i. One for diagnosis (lymph node or bone marrow biopsy)

ii. One palpable for treatment

iii. One measurable radiographically

3. > 60 days after RIC allogeneic transplant for lymphoma

4. 18 years of age or older

5. Mixed (5-95%) or complete (>95%) chimerism

6. Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2

7. ANC >1000/mm3, platelets >50,000/mm3

8. Total bilirubin ≤ 2.5 mg/dL, AST and ALT < 3 times upper limit of normal

9. Serum creatinine ≤ 3 mg/dL

10. No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to
scheduled treatment

11. 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

1. HIV associated lymphoma

2. Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)

3. Active infection within 14 days prior to scheduled treatment

4. Active Cytomegalovirus (CMV) disease at the time of enrollment

5. Pre-existing autoimmune or antibody mediated disease (including systemic lupus
erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and
autoimmune thrombocytopenia)

6. Pregnant

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

60 Days

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

BMT235

NCT ID:

NCT01745354

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317