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A Phase I/II Study of Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase I/II Study of Intratumoral Dendritic Cell Vaccination Combined With Local Radiotherapy in Patients With Recurrent Lymphoma.

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.

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and feasibility of intratumoral dendritic cell vaccination

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Karolina Palucka, MD, PhD

Investigator Role:

Study Director


United States: Food and Drug Administration

Study ID:

Baylor IRB #007-082



Start Date:

July 2008

Completion Date:

March 2010

Related Keywords:

  • Lymphoma
  • Lymphoma, Dendritic, Vaccine, Radiotherapy
  • Lymphoma



Baylor University Medical CenterDallas, Texas  75246