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

Lymphoma, Follicular Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00081809
• Other study ID #: C-100-09
• Secondary ID: MDACC Protocol I
• Status: Completed
• Phase: Phase 2
• Start date: March 2000
• Est. completion date: June 2005

Study information

• Verified date: September 2023
• Source: Agenus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Small Lymphocytic

Intervention

Drug:
• autologous human tumor-derived HSPPC-96

Locations

Country	Name	City	State
United States	M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Agenus Inc.

Country where clinical trial is conducted

United States,