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A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

Phase 2
Not Enrolling
Lymphoma, Follicular, Lymphoma, Small Lymphocytic

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Trial Information

A Phase II Trial of Active Specific Immunotherapy in Patients With Indolent Lymphoma Using Autologous Lymphoma-Derived Heat Shock Protein-Peptide Complex (HSPPC-96)

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

- A minimum of 2 grams of non-necrotic, resectable malignant lymphoma for HSPPC-96

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

March 2000

Completion Date:

June 2005

Related Keywords:

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



M.D. Anderson Cancer Center Houston, Texas  77030