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

B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00880867
• Other study ID #: NVCI-0838
• Status: Terminated
• Phase: Phase 1
• First received: April 10, 2009
• Last updated: July 19, 2011
• Start date: April 2009
• Est. completion date: April 2011

Study information

• Verified date: July 2011
• Source: Nevada Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, T-Cell
• T Cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	Nevada Cancer Institute	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Nevada Cancer Institute	CLL Topics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity (DLT)		Days 1 through 4 during weeks 1, 2, 3, 4, and 8	Yes
Secondary	Tumor Response		Weeks 1 through 4, 8, 12, 16, and q3 months thereafter	No