Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
Condition: Mantle Cell Lymphoma; Lymphoma, Mantle Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: EPOCH-R; GM-CSF; Idiotype vaccine
Intervention description: EPOCH-R for 6 cycles; Granulocyte-macrophage colony-stimulating factor (GM-CSF) monthly with the vaccine for 5 doses; 1 injection of vaccine monthly for 5 doses
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Etoposide; Vincristine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoma Vaccines; Immune Response Against Lymphoma; Molecular Complete Remissions; Novel Treatment Approach; Mantle Cell Lymphoma

Summary:

      This study will evaluate the safety and effectiveness of an experimental cancer vaccine for
      mantle cell lymphoma a form of cancer of the white blood cells called lymphocytes. Although
      standard treatments for lymphoma may achieve disease remission, none provides a cure.

      Patients with mantle cell lymphoma 18 years and older who have not been treated previously
      with chemotherapy may participate in this study. Candidates will be screened for eligibility
      with a medical history and physical examination. Other tests that may be required include
      blood and urine tests; lung function studies; imaging tests such as magnetic resonance
      imaging, computed tomography and X-rays; and biopsy (surgical removal of a small tissue
      sample) of tumor, bone marrow, or other tissue.

      Patients enrolled in the study will begin treatment with chemotherapy designed to reduce
      disease to a minimum that is, to achieve remission or shrink the tumor as much as possible.
      Chemotherapy will be administered on an outpatient basis over a period of around 12 to 18
      weeks in 3-week cycles as follows: prednisone by mouth on days 1 through 5; etoposide,
      doxorubicin and vincristine intravenously through (a vein) on days 1 through 5; and
      cyclophosphamide intravenously on day 5. Starting day 6, patients receive no chemotherapy for
      16 days. In addition, an antibody called rituximab, which attaches to lymphoma cells and may
      increase the effectiveness of the chemotherapy, will be given on day 1 of the cycle. Patients
      will also receive a protein called granulocyte colony-stimulating factor (G-CSF) starting day
      6 of the cycle and continuing until the white blood cell count recovers or until day 19.
      G-CSF is naturally produced by bone marrow and may boost the immune system. The chemotherapy
      drugs and rituximab are infused through a vein by means of a lightweight portable pump, which
      patients are taught how to use. Patients are also how taught how to give themselves G-CSF
      injections under the skin, similar to insulin injections.

      The first vaccination will be given at least 3 months after chemotherapy ends and will be
      repeated every 4 weeks for a maximum of 5 vaccinations. The vaccinations will be given in the
      clinic. Patients will also receive daily injections of granulocyte-macrophage
      colony-stimulating factor (GM-CSF), a growth factor naturally produced by bone marrow that
      can boost the immune system. These injections will be given the day of the vaccination and
      for the next 3 days.

      When vaccine therapy is completed, patients who were treated successfully will be followed
      with periodic clinic visits for follow-up examinations and tests. Patients in whom the
      lymphoma did not disappear entirely or who have a recurrence of disease will be advised of
      further treatment possibilities....
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Tissue diagnosis of mantle cell lymphoma (confirmed in Laboratory of Pathology). Blastic
        cell variant will be eligible.

        Age greater than or equal to 18.

        Previously untreated with cytotoxic chemotherapy. Patients may have received local
        radiation or a short course of steroids for control of symptoms.

        All stages of disease.

        Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater than
        1000/microliters of circulating tumor cells in the blood.

        Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3.

        Adequate major organ function (serum creatinine 1.5 mg/dl or creatinine clearance greater
        than 60 ml/min; bilirubin less than 2 mg/dl (total) except less than 5 mg/dl in patients
        with Gilbert's syndrome as defined by greater than 80% unconjugated; absolute neutrophil
        count (ANC) greater than 1000 and platelets greater than 100,000) unless impairment due to
        organ involvement by lymphoma.

        No active symptomatic ischemic heart disease, myocardial infarction or congestive heart
        failure within the past year. If multigated acquisition (MUGA) scan is obtained, the left
        ventricular ejection fraction (LVEF) should exceed 40%.

        Ability to give informed consent.

        EXCLUSION CRITERIA:

        Antibodies to human immunodeficiency virus (HIV) or presence of hepatitis B surface
        antigen.

        Pregnant or lactating.

        Prior malignancy in past 5 years except squamous or basal cell carcinoma or curatively
        treated in situ of the cervix.

        Involvement of central nervous system by lymphoma.