Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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|
- Toxicity (DLT) [ Time Frame: Days 1 through 4 during weeks 1, 2, 3, 4, and 8 ] [ Designated as safety issue: Yes ]
- Tumor Response [ Time Frame: Weeks 1 through 4, 8, 12, 16, and q3 months thereafter ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Poly-ICLC plus low dose local radiation.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880867
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|Principal Investigator:||Delva Deauna-Limayo, MD||Nevada Cancer Institute|