Clinical trial NCT00081809: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2004-04-23
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
References: