Dendritic Cell Vaccine in Treating Patients With Indolent B-Cell Lymphoma or Multiple Myeloma - Full Text View

Sponsor:	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00937183

Purpose

RATIONALE: Biological therapies, such as a dendritic cell vaccine made with a patient's cancer cells, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase I/II trial is studying the side effects of dendritic cell vaccine and to see how well it works in treating patients with indolent B-cell lymphoma or multiple myeloma.

Condition	Intervention	Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm	Biological: autologous lymphoma cell lysate-pulsed autologous dendritic cell vaccine Biological: autologous lymphoma cell/allogeneic dendritic cell electrofusion hybrid vaccine Biological: autologous lymphoma cell/autologous dendritic cell electrofusion hybrid vaccine	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Vaccination of Lymphoma Patients With Dendritic Cell-Lymphoma Cell Hybrids and Dendritic Cells Pulsed With Tumor Lysates

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immune response [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2003
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Evaluation of feasibility of dendritic cell (DC)-based vaccination program using autologous tumor cells and/or lysates in patients with indolent B cell lymphomas or multiple myeloma as an adjuvant therapy to induce immune response in remission after cytoreductive treatment.
Evaluation of the immune response of patients treated with this regimen.
Evaluation the progression-free survival of patients treated this regimen.
Evaluate the adverse events of this regimen in these patients.

OUTLINE: Patients receive intranodal (under ultrasound guidance) or subcutaneous vaccinations of adjuvant electrofusion hybrids of autologous dendritic cells (DC) with autologous lymphoma cells, electrofusion hybrids of allogeneic DC with autologous lymphoma cells, and/or autologous DC pulsed with autologous tumor lysate cells in weeks 0, 2, 4, 8, 12, 18, 26, and 50.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
- Mantle cell lymphoma
- Marginal zone lymphoma
- Follicular lymphoma
- Small lymphocytic lymphoma/chronic lymphocytic leukemia
- Multiple myeloma
- Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia
- Diffuse large B-cell lymphoma
Adequate sample size and lymphoma cell content in the fresh tissue collected
No bulky or progressive disease

PATIENT CHARACTERISTICS:

Life expectancy > 3 months
No evidence of lung, heart, liver, or renal failure or severe neurologic disorder
No autoimmune disease or atopic allergy
No HIV positivity
No other malignancy

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937183

Locations

Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw	Recruiting
Warsaw, Poland, 02-781
Contact: Jan Walewski, MD 48-22-546-2223 walewski@coi.waw.pl

Sponsors and Collaborators

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Investigators

Study Chair:

Jan Walewski, MD

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00937183 History of Changes
Other Study ID Numbers:	CDR0000636859, MSCMI-40/2003, EU-20913
Study First Received:	July 8, 2009
Last Updated:	July 3, 2010
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

Waldenstrom macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
stage I grade 1 follicular lymphoma
stage I grade 2 follicular lymphoma
stage I grade 3 follicular lymphoma
stage II grade 1 follicular lymphoma
stage II grade 2 follicular lymphoma
stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage I small lymphocytic lymphoma
stage II small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage I marginal zone lymphoma

stage II marginal zone lymphoma
stage III marginal zone lymphoma
stage I adult diffuse large cell lymphoma
stage II adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
B-cell chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 24, 2012