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A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

Primary Purpose

Lymphoma, Follicular, Lymphoma, Small Lymphocytic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous human tumor-derived HSPPC-96
Sponsored by
Agenus Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Follicular focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • M.D. Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 20, 2004
Last Updated
September 26, 2023
Sponsor
Agenus Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00081809
Brief Title
A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agenus Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular, Lymphoma, Small Lymphocytic
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
autologous human tumor-derived HSPPC-96

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma

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