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A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
This study has been completed.
First Received: April 20, 2004   Last Updated: April 19, 2006   History of Changes
Sponsored by: Antigenics
Information provided by: Antigenics
ClinicalTrials.gov Identifier: NCT00081809
  Purpose

Primary Objectives:

  • To document the efficacy of treatment with autologous lymphoma-derived HSPPC-96 of selected patients with indolent lymphoma. The efficacy endpoints are:
  • the rate of complete and partial responses
  • the time to progression.

Secondary Objectives:

  • To evaluate the safety and tolerability of autologous tumor-derived heat-shock protein peptide complex (HSPPC-96) administered intradermally once weekly for four consecutive weeks, followed by HSPPC-96 administered once every two weeks.
  • To evaluate the feasibility of autologous HSPPC-96 preparation from lymphoma specimens.
  • To assess approximately the composition of the tissue source of the autologous HSPPC-96 for each patient.
  • To study the effect of autologous lymphoma-derived HSPPC-96 vaccine therapy on the expression of Fas ligand and TRAIL death proteins in peripheral blood lymphocytes of patients with indolent lymphoma.

Condition Intervention Phase
Lymphoma, Follicular
Lymphoma, Small Lymphocytic
Drug: autologous human tumor-derived HSPPC-96
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

Resource links provided by NLM:


Further study details as provided by Antigenics:

Estimated Enrollment: 35
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with previously treated or newly diagnosed follicular center cell grade I or grade II lymphoma, small lymphocytic lymphoma, MALT lymphoma, monocytoid B-cell lymphoma, Waldenstrom’s macroglobulinemia, or marginal zone lymphoma with bidimensionally measurable disease;
  • Part of the resected specimen must undergo routine pathologic examination to confirm the diagnosis of lymphoma. The remaining tissue must be used for the preparation of autologous HSPPC-96;
  • Autologous HSPPC-96 vaccine must be successfully prepared and provided by the sponsor;
  • A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96 preparation;
  • Bidimensionally measurable disease in at least one location other than the resected lymphoid tissue;
  • Life expectancy of at least 16 weeks;
  • Zubrod performance status of less then or equal to 2;
  • Adequate bone marrow function;
  • Adequate hepatic function;
  • Adequate renal function;
  • Signed written informed consent;
  • Patients of child-bearing potential must practice contraception, which is adequate in the opinion of the Principal Investigator;
  • Patients of child-bearing potential must have a negative serum pregnancy test prior to entry into the study and must not be lactating;
  • Patients must be willing to be followed at the M. D. Anderson Cancer Center during the course of treatment and follow-up;
  • Electrocardiogram if none performed in the prior six months;
  • Patients must have no chemotherapy, immunotherapy, radiotherapy, or experimental anti-cancer therapy within six weeks prior to starting autologous HSPPC-96 administration;
  • Patients must have fully recovered from prior anti-cancer therapy;
  • Tumor measurements and staging no more than 4 weeks prior to receiving the first dose of autologous HSPPC-96.

Exclusion Criteria:

  • Patients with active or prior history of central nervous system lymphoma;
  • Patients with serious intercurrent medical illnesses, requiring hospitalization;
  • Patients with a history of primary or secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on functional immune system) or patients taking immunosuppressive drugs such as systemic corticosteroids;
  • Women who are pregnant or lactating;
  • Patients participating in another clinical trial;
  • Patients receiving growth factors of any kind, including G-CSF, GM-CSF, or Epogen;
  • Patients with bulky disease, defined as greater than 10 cm in diameter;
  • Patients with positive HIV antibody;
  • Patients with more than 4 previous treatment regimens will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081809

Locations
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Antigenics
  More Information

Additional Information:
No publications provided

Study ID Numbers: C-100-09, MDACC Protocol ID99-354
Study First Received: April 20, 2004
Last Updated: April 19, 2006
ClinicalTrials.gov Identifier: NCT00081809     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Antigenics:
non-Hodgkin's lymphoma
Brill-Symmers Disease
Follicular Lymphoma
Lymphoma, Giant Follicular
Lymphoma, Nodular
Follicular Lymphoma, Giant
Giant Follicular Lymphoma
Lymphocytic Lymphoma, Diffuse, Well-Differentiated
Lymphocytic Lymphoma, Well-Differentiated
Lymphoma, Lymphocytic, Diffuse, Well-Differentiated
Lymphoma, Lymphocytic, Well-Differentiated
Lymphoma, Lymphoplasmacytoid, CLL
Lymphoma, Small Lymphocytic, Plasmacytoid
Lymphoplasmacytoid Lymphoma, CLL
Diffuse Well-Differentiated Lymphocytic Lymphoma
Lymphocytic Lymphoma, Diffuse, Well Differentiated
Lymphocytic Lymphoma, Well Differentiated
Lymphoma, Lymphocytic, Diffuse, Well Differentiated
Lymphoma, Lymphocytic, Well Differentiated
Lymphoma, Mucosa-Associated Lymphoid Tissue
MALT Lymphoma
Lymphoma of Mucosa-Associated Lymphoid Tissue
Mucosa-Associated Lymphoid Tissue Lymphoma
Monocytoid B-cell lymphoma
Waldenstrom’s macroglobulinemia
Marginal zone lymphoma

Study placed in the following topic categories:
Leukemia, Lymphoid
Immunoproliferative Disorders
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Follicular Lymphoma
Lymphoma, Small Cleaved-cell, Diffuse
Lymphoma, B-Cell
Leukemia
Lymphatic Diseases
Chronic Lymphocytic Leukemia
Waldenstrom Macroglobulinemia
B-cell Lymphomas
Shock
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Follicular
Leukemia
Lymphatic Diseases
Neoplasms
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 10, 2009