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

NCT00880867 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2011-07-20

No results posted yet for this study

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.

Conditions

  • B Cell Lymphoma
  • T Cell Lymphoma

Interventions

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.

Sponsors & Collaborators

  • CLL Topics

    collaborator UNKNOWN

  • Nevada Cancer Institute

    lead OTHER

Principal Investigators

  • Delva Deauna-Limayo, MD · Nevada Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00880867 on ClinicalTrials.gov