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

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Agenus

Status and phase

Completed
Phase 2

Conditions

Lymphoma, Follicular
Lymphoma, Small Lymphocytic

Treatments

Drug: autologous human tumor-derived HSPPC-96

Study type

Interventional

Funder types

Industry

Identifiers

NCT00081809
C-100-09
MDACC Protocol ID99-354

Details and patient eligibility

About

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.

Sex

All

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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