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Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT00849524 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-12-30

Study results available
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Summary

This is a Phase II, open label, fixed dose, repeat injection, single institution study. Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.

Conditions

Interventions

BIOLOGICAL

ISF35

Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10\^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Memgen, LLC

    collaborator INDUSTRY

  • Januario Castro, M.D.

    lead OTHER

Principal Investigators

  • Januario Castro, M.D. · Associate Clinical Professor in the Blood and Marrow Transplantation Division

  • Thomas J Kipps, M.D., Ph.D. · Professor of Medicine, Evelyn and Edwin Tasch Chair in Cancer Research in the UCSD School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT00849524 on ClinicalTrials.gov