Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma
Conditions
B-cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, B-Cell
Conditions: Keywords
Low Grade B-cell Lymphoma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SD-101 Type: Drug
Name: Radiation therapy Type: Radiation
Overall Status
Recruiting
Summary
To assess the safety and tolerability of escalating doses of SD-101 in combination with localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell lymphoma.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Biopsy confirmed, untreated, low-grade B-cell lymphoma, including follicular (Grade 1, 2, or 3A [WHO 2008]) or marginal, or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with lymph node involvement

- At least 2 sites of measurable disease, 1 of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection and a second that will not be included in the radiation field of the treated tumor

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

- Aged 18 years and older

- Absolute neutrophil count > 1000/mm3

- Platelet count > 75,000/µL

- Serum creatinine (Cr) < 2.0 mg/dL or estimated glomerular filtration rate (eGFR, calculated using modification in diet by renal disease [MDRD]) ≥ 30 mL/min/1.73 m2

- Total bilirubin < 1.5 times the upper limit of normal

- Aspartate aminotransferase (AST)/alanine aminotransferase ALT) < 3 times the upper limit of normal

- Women of childbearing potential (WOCBP) must be willing to use a medically acceptable method of contraceptive during study. Acceptable birth control methods include oral contraceptive medication, an intrauterine device (IUD), an injectable contraceptive (such as Depo-Provera®), a birth control patch, or a barrier method (such as condom or diaphragm with spermicide)

- Either a fresh or archived tumor specimen must be available for central confirmation of diagnosis and correlative studies

- Ability to understand and sign informed consent form and comply with treatment protocol

Exclusion Criteria:

- Human immunodeficiency virus (HIV)-positive or HIV-associated lymphoma

- Hepatitis B or hepatitis C infection

- Diagnosis of mantle or diffuse large-cell lymphoma, Grade 3B follicular lymphoma (WHO 2008), or gastric mucosa-associated lymphoid tissue (MALT) lymphoma

- Clinically significant pleural effusion

- Active infection including cytomegalovirus

- Pregnant or breast feeding

- Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjӧgren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant

- Lymphoma involvement of the central nervous system

- Received any prior therapy for lymphoma

- Use of any investigational agent within the last 28 days

- Serious, non-healing wound, ulcer, or bone fracture

- Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day -1 (Visit 1); Grade II or greater peripheral vascular disease at study entry

- Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study

- History of sensitivity to any component of SD-101

- Has had a diagnosis of cancer within the last 5 years other than B-cell lymphoma, except curatively treated early stage carcinomas with no evidence of recurrence

- Is taking systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
Locations
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Northwestern University
Chicago, Illinois, United States
Status: Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Status: Recruiting
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Status: Recruiting
Start Date
October 2014
Sponsors
Dynavax Technologies Corporation
Source
Dynavax Technologies Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page