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

Phase 1
18 Years
Not Enrolling
B Cell Lymphoma, T Cell Lymphoma

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Trial Information

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

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

3. Patients must have at least one accessible tumor site that can be injected with

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity (DLT)

Outcome Time Frame:

Days 1 through 4 during weeks 1, 2, 3, 4, and 8

Safety Issue:


Principal Investigator

Delva Deauna-Limayo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nevada Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

April 2009

Completion Date:

April 2011

Related Keywords:

  • B Cell Lymphoma
  • T Cell Lymphoma
  • Low Grade Recurrent B and T Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell



Nevada Cancer Institute Las Vegas, Nevada  89135