- 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.
- 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.
- 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 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
- 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.
- 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.