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

NCT00637117 | Withdrawn Phase 1 DMC

• 1 other identifier: 007-082
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lymphoma

Keywords

Lymphoma, Dendritic, Vaccine, Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility of intratumoral dendritic cell vaccination

  2 years

Secondary Outcomes (2)

• Clinical activity-response in local and distant lesions

  2 years

• Immunological response with conventional CTL assay, proliferation assay and microarray-based immune gene profiling using peripheral blood and/or biopsied tumor

  2 years

Interventions

Autologous dendritic cells generated using GM-CSF, interferon alpha and LPS BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

MeSH Terms

Conditions

Lymphoma

Interventions

Interferon-alpha; Lipopolysaccharides

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Endotoxins; Bacterial Toxins; Toxins, Biological

Study Officials

• Karolina Palucka, MD, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 12, 2017

Record last verified: 2017-06