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

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Brief Title

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

Official Title

A Phase I Study of Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Toxicity (DLT)

Secondary Outcome

 Tumor Response

Condition

B Cell Lymphoma

Intervention

Poly-ICLC

Study Arms / Comparison Groups

 Poly-ICLC
Description:  Poly-ICLC plus low dose local radiation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

April 2009

Completion Date

April 2011

Primary Completion Date

May 2010

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Delva Deauna-Limayo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00880867

Organization ID

NVCI-0838



Study Sponsor

Nevada Cancer Institute

Collaborators

 CLL Topics

Study Sponsor

Delva Deauna-Limayo, MD, Principal Investigator, Nevada Cancer Institute


Verification Date

July 2011