Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

This study has been withdrawn prior to enrollment.
(The study never opened and not sure if it ever will.)
Sponsor:
Information provided by:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00637117
First received: March 10, 2008
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

The purpose of the study is to gather data on feasibility and on immune and clinical efficacy of intratumoral dendritic cell (DC) vaccination in combination with local radiotherapy in patients with recurrent lymphoma


Condition Intervention Phase
Lymphoma
Biological: Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Safety and feasibility of intratumoral dendritic cell vaccination [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical activity-response in local and distant lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Immunological response with conventional CTL assay, proliferation assay and microarray-based immune gene profiling using peripheral blood and/or biopsied tumor [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS
    Day 1 and Day 2: 2 Gy Radiation on Day 1 and Day 2 to tumor site. Day 4, 8, 11, 18: 0.5mL injection of Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS.
Detailed Description:

Lymphoma is extremely sensitive to radiation and is a commonly used therapy. The major issue in application of local radiotherapy is the relative short duration of response and as a consequence is used mainly for palliation. Therefore novel therapies are needed to improve the outcome of patients with lymphomas. The potential specificity of the immune system to recognize and eliminate tumor cells is especially relevant in lymphoma. Immune responses are induced, coordinated and regulated by dendritic cells (DCs), the most potent antigen-presenting cells. Based on the central role of DCs in initiating immune responses, four vaccinations will be administered at intervals beginning two days after low dose radiation is given to the tumor site.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed recurrent lymphoma of any initial stage, either Hodgkin's lymphoma or the B cell or T cell NHL of an indolent nature. For B cell lymphoma, follicular lymphoma, small lymphocytic lymphoma, marginal zone lymphoma, and those indolent patients with mantle cell lymphoma or diffuse large B cell lymphoma will be included. For T cell lymphoma, the patients with indolent cutaneous T cell lymphomas (mycosis fungoides or primary cutaneous anaplastic large cell lymphoma) who have failed or have been intolerant of one systemic or two topical treatments will be included.
  • Patients must have failed at least one line of prior treatment but not more than four (including autologous but not allogeneic stem cell transplant).
  • Patients must have at least one site of disease that is accessible for intratumoral injection of DCs percutaneously after palliative local radiotherapy
  • Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the treatment.
  • Patients must have measurable disease other than the injection site or biopsy site.
  • 18 years of age or older.
  • Karnofsky Performance Status (KPS) of > 70.
  • Adequate bone marrow function: WBC >2000/uL, platelet count >75,000/mm3; ANC>1000.
  • Adequate hepatic function: bilirubin <= 1.5 mg/dL; SGOT/SGPT<2.5x upper limit of normal
  • Adequate renal function: serum creatinine <= 2.0mg/dL.
  • Required wash out periods for prior therapy:
  • Topical therapy: 2 weeks
  • Chemotherapy: 4 weeks (12 weeks for purine analogs)
  • Radiotherapy (including photo therapy): 4 weeks
  • Other systemic biological therapy: 4 weeks
  • Other investigational therapy: 4 weeks
  • Patients of reproductive potential and their partners must agree to use an effective (>90% reliability) form of contraception during the study and for 4 weeks following the last study drug administration.
  • Women of reproductive potential must have negative urine pregnancy test.
  • Life expectancy greater than 4 months.
  • Able to comply with the treatment schedule.

Exclusion Criteria:

  • Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  • Known history of human immunodeficiency virus (HIV) or hepatitis B or C.
  • CNS metastases
  • 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.
  • Current anticoagulant therapy (ASA<= 325 mg/day allowed).
  • Significant cardiovascular disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction with the past 6 months; unstable angina; coronary angioplasty with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
  • Pregnant or lactating.
  • Prior therapy with allogeneic stem cell transplant.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637117

Sponsors and Collaborators
Baylor Research Institute
Investigators
Study Director: Karolina Palucka, MD, PhD
  More Information

No publications provided

Responsible Party: Wenru Song, MD, PhD, Baylor Institute for Immunology Research
ClinicalTrials.gov Identifier: NCT00637117     History of Changes
Other Study ID Numbers: Baylor IRB #007-082
Study First Received: March 10, 2008
Last Updated: August 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
Lymphoma, Dendritic, Vaccine, Radiotherapy

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Interferon-alpha
Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014