|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Nevada Cancer Institute |
|---|---|
| Collaborator: |
CLL Topics |
| Information provided by: | Nevada Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00880867 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
B Cell Lymphoma T Cell Lymphoma |
Drug: Poly-ICLC |
Phase I |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 3 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required washout period for prior therapy:
Exclusion Criteria:
Contacts and Locations| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States, 89135 | |
| Principal Investigator: | Delva Deauna-Limayo, MD | Nevada Cancer Institute |
More Information
| Responsible Party: | Delva Deauna-Limayo, MD, Nevada Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00880867 History of Changes |
| Other Study ID Numbers: | NVCI-0838 |
| Study First Received: | April 10, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Low Grade Recurrent B and T Cell Lymphoma |
|
Lymphoma Lymphoma, B-Cell Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Poly ICLC Interferon Inducers Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |