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Trial record 50 of 2043 for:    cancer vaccine

Phase II Cancer Vaccine Trial for Patients With Follicular Lymphoma (Lymvac-1)

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ClinicalTrials.gov Identifier: NCT01926639
Recruitment Status : Completed
First Posted : August 21, 2013
Last Update Posted : October 23, 2014
Sponsor:
Collaborators:
Norwegian Cancer Society
Helse Sor-Ost
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:
Patients with non-curable disseminated follicular lymphoma receive local radiotherapy targeting single lymph nodes and injection of low-dose rituximab (anti-CD20) and autologous dendritic cells. The therapy is repeated 3 times, targeting different lesion. Aims are to induce tumor immunity and clinical responses.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Biological: Radiotherapy, rituximab and DC Phase 2

Detailed Description:
The clinical protocol is based on the rationale that the immune system has been developed to combat infectious disease. To mimic the environment in infected tissue, selected tumor-affected lymph nodes are treated locally with a single dose of 8 Gy radiotherapy and injected with therapeutic antibody (anti-CD20/Rituximab). Later, dendritic cells (DC) are injected into the damaged tumor tissue together with a stimulatory cytokine (GM-CSF) to initiate an immune response. Patients with untreated or relapsed stage III/IV follicular lymphoma not in need of standard therapy receive intra-tumoral injections of low-dose anti-CD20 antibodies (5 mg) on days 1 and 3 and local radiotherapy on day 2. On days 4 and 5, dendritic cells generated from monocytes isolated from the patients blood are injected into the site together with the stimulatory cytokine GM-CSF administered subcutaneously. Additional lymph nodes are treated similarly after 2 and 4 weeks. The treatment is thus performed three times, targeting different lymphoma nodes. The primary aims are to induce tumor-specific immune responses and clinical responses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Combined With Intratumoral Injections of Dendritic Cells and Rituximab - a Phase II Cancer Vaccine Trial for Patients With Untreated and Relapsed Indolent Non-Hodgkin's Lymphoma
Study Start Date : October 2009
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Radiotherapy , rituximab and DC
Treatment repeated 3 times and targeting different lymph nodes
Biological: Radiotherapy, rituximab and DC
Lymphoma lymph nodes are irradiated with 8 Gy single treatment and injected with rituximab (5 mg) and autologous DC intratumorally. The treatment is performed 3 times targeting different lymph nodes




Primary Outcome Measures :
  1. Response rate [ Time Frame: 5 years ]
    Clinical response measured by CT and PET/CT and immune response


Secondary Outcome Measures :
  1. Immune response [ Time Frame: 1 year ]
    Immune response measured by flow cytometry. Peripheral blood mononuclear cells before and after treatment are cultures along with autologous tumor cells. Proliferation is measured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years and older
  2. Histologically confirmed (by WHO classification) untreated and relapsed indolent non-Hodgkin's B-cell lymphoma of low-grade follicular, marginal zone, lymphoplasmocytic or small lymphocytic subtypes.
  3. Stage III/IV
  4. Adequate bone marrow function (leukocyte count>2,0, neutrophil count>1.0, platelets>50)
  5. Two or more separate lymph nodes > 1,5 cm available for biopsy or treatment.
  6. Measurable disease present other than biopsy site and injection site(s).
  7. Required wash-out period after previous treatment: Chemotherapy - 8 weeks, Radiotherapy - 4 weeks, Rituximab - 12 weeks
  8. WHO status 0-1
  9. Life expectancy of more than 6 months
  10. Written informed consent
  11. Able to comply with the treatment protocol -

Exclusion Criteria:

  1. Patients with progressive lymphoma in need of systemic therapy or standard dose irradiation.
  2. Chronic bacterial, viral or fungal infection
  3. Pre-existing autoimmune or antibody mediated disease including: systemic lupus, erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the presence of autoantibodies without clinical autoimmune disease.
  4. Known history of HIV
  5. Central nervous system involvement of lymphoma
  6. Current anticoagulant therapy which can not safely be paused during treatment injections (ASA < 325 mg/day allowed)
  7. Pregnancy -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926639


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0310
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
Helse Sor-Ost
Investigators
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Study Chair: Arne Kolstad, MD, PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01926639    
Other Study ID Numbers: 2.2007.1112 Lymvac-1
2007-002153-23 ( EudraCT Number )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014
Keywords provided by Oslo University Hospital:
Follicular lymphoma
Rituximab
Autologous dendritic cells
Cancer vaccine
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents