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

This study is currently recruiting participants.

Verified December 2012 by Stanford University

Sponsor:

Information provided by (Responsible Party):

Stanford University

ClinicalTrials.gov Identifier:

NCT01745354

First received: December 6, 2012

Last updated: NA

Last verified: December 2012

History: No changes posted

Purpose

Direct intratumoral injection of SD-101 with local radiation is safe in patients with relapsed or refractory lymphoma after allogeneic hematopoietic cell transplant.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Measure tumor response by PET-CT scan imaging [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
Measure level of donor specific tumor infiltrating lymphocytes by flow cytometry and Immunofluorescence [ Time Frame: 2, 3, 8 weeks after treatment ] [ Designated as safety issue: No ]
Collect PBMCs

Estimated Enrollment:	12
Study Start Date:	August 2012
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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).

Eligibility

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

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

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

ii. One palpable for treatment

iii. 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745354

Contacts

Contact: Lauren Maeda

650-498-6000

lmaeda@stanford.edu

Locations

United States, California
Stanford University School of Medicine	Recruiting
Palo Alto, California, United States, 94305
Contact: Robert Lowsky 650-723-0822 rlowsky@stanford.edu
Sub-Investigator: Edgar G Engleman
Sub-Investigator: Richard T Hoppe
Sub-Investigator: Ronald Levy
Sub-Investigator: Lauren Maeda
Sub-Investigator: Samuel Strober

Sponsors and Collaborators

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01745354 History of Changes
Other Study ID Numbers:	BMT235, SU-07212011-8129, 20741
Study First Received:	December 6, 2012
Last Updated:	December 6, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:

Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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