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A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
This study has been completed.

First Received on April 20, 2004.   Last Updated on April 19, 2006   History of Changes
Sponsor: 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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

ClinicalTrials.gov Identifier: NCT00081809     History of Changes
Other Study ID Numbers: C-100-09, MDACC Protocol ID99-354
Study First Received: April 20, 2004
Last Updated: April 19, 2006
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

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

ClinicalTrials.gov processed this record on February 12, 2012