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

NCT ID: NCT01745354

Last Updated: 2016-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-11-30

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.

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).

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SD-101 + Combined with Local Radiation

Group Type: EXPERIMENTAL

SD-101

Intervention Type: DRUG

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

Local Radiation

Intervention Type: RADIATION

Interventions

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

Intervention Type: DRUG

Local Radiation

Intervention Type: RADIATION

Other Intervention Names

Dynavax

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Lowsky

OTHER

Sponsor Role: lead

Responsible Party

Robert Lowsky

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Lowsky

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Lauren Maeda

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

SU-07212011-8129

Identifier Type: OTHER

Identifier Source: secondary_id

20741

Identifier Type: OTHER

Identifier Source: secondary_id

BMT235

Identifier Type: -

Identifier Source: org_study_id