Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00880867
Recruitment Status : Terminated (Low enrollment)
First Posted : April 14, 2009
Last Update Posted : July 20, 2011
CLL Topics
Information provided by:
Nevada Cancer Institute

Brief Summary:
The primary objective of this study is to evaluate the safety of intratumoral Polyinosinicpolycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC)(Hiltonol®) in addition to low-dose local radiotherapy for adult patients with low grade lymphomas, including follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia, and cutaneous T-cell lymphoma. The secondary endpoints are response rate, immune responses, and durability of responses as well as generation of antiinflammatory response at sites of tumor involvement.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma T Cell Lymphoma Drug: Poly-ICLC Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma
Study Start Date : April 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Poly-ICLC
Poly-ICLC plus low dose local radiation.
Drug: Poly-ICLC
An accessible site of disease (lymph node, cutaneous, subcutaneous, etc.) will be selected by the principal investigator. Patients will then receive two doses of low dose irradiation (2 Gy per day) to that single site on days 1 and 2. Intratumorally or peritumorally Poly-ICLC will be dosed on days 3 and 4 by the physician during weeks 1, 2, 3, 4, and 8.
Other Name: Hiltonol

Primary Outcome Measures :
  1. Toxicity (DLT) [ Time Frame: Days 1 through 4 during weeks 1, 2, 3, 4, and 8 ]

Secondary Outcome Measures :
  1. Tumor Response [ Time Frame: Weeks 1 through 4, 8, 12, 16, and q3 months thereafter ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be at least 18 years of age.
  2. Patients must have biopsy confirmed low-grade B-cell lymphoma (follicular, marginal zone, or small cell/chronic lymphocytic leukemia) or mycosis fungoides. B-cell lymphoma patients must have failed at least one prior therapy (chemotherapy or immunotherapy) or mycosis fungoides patients failed at least 1 topical or systemic treatment.
  3. Patients must have at least one accessible tumor site that can be injected with poly-ICLC.
  4. Patients must have measurable disease other than the injection site.
  5. Patients must have a Karnofsky performance status of at least 70%.
  6. Patients must have adequate hematologic, renal and liver function (i.e., absolute neutrophil count at least 1500/mm3, Platelets at least 100,000/mm3, creatinine no more than 1.7 mg/dl, total bilirubin no more than 1.5 mg/dl, transaminases no more than 4 times above the upper limits of the institutional normal).
  7. Patients must be able to provide written informed consent.
  8. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. While animal testing has been negative, the anti-proliferative activity of this experimental drug may theoretically be harmful to the developing fetus or nursing infant.
  9. Required washout period for prior therapy:

    • Topical therapy: 2 weeks.
    • Chemotherapy: 4 weeks
    • Radiotherapy: (including phototherapy): 4 weeks 13 of 26
    • Biological therapies: 4 weeks
    • Other investigational therapy: 4 weeks
    • Rituximab: 12 weeks

Exclusion Criteria:

  1. Any history of autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, autoimmune hemolytic anemia, pure red cell aplasia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  2. Off nucleoside or bendustine therapy for a minimum of 6 months
  3. Prior treatment with Campath
  4. Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both).
  5. Patients with active infection or with a fever > 38.5°C within three days prior to the first scheduled treatment.
  6. CNS metastases.
  7. Prior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervix.
  8. Current anticoagulant therapy (ASA no more than 325 mg/day allowed).
  9. Significant cardiovascular disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
  10. Pregnant or lactating.
  11. Any other medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00880867

United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Sponsors and Collaborators
Nevada Cancer Institute
CLL Topics
Principal Investigator: Delva Deauna-Limayo, MD Nevada Cancer Institute

Responsible Party: Delva Deauna-Limayo, MD, Nevada Cancer Institute Identifier: NCT00880867     History of Changes
Other Study ID Numbers: NVCI-0838
First Posted: April 14, 2009    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011

Keywords provided by Nevada Cancer Institute:
Low Grade Recurrent B and T Cell Lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Poly I-C
Carboxymethylcellulose Sodium
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents