Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Dexamethasone; Autologous Tumor Cell-Based Vaccine; IL-2
Intervention description: Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.; Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.; Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.; Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.; Participants receive conventional chemotherapy comprising 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.; Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.; Participants receive vaccine comprising autologous tumor cells and GM.CD40L intradermally on day 1 and low-dose interleukin-2 (IL-2) subcutaneously twice daily on days 1-14. Treatment repeats every 28 days for 4 courses. Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2 as above.
Intervention MeSH terms: Aldesleukin; Dexamethasone; Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent mantle cell lymphoma; contiguous stage II mantle cell lymphoma; noncontiguous stage II mantle cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma

Summary:

      RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the
      body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may
      stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a
      stronger immune response and prevent or delay the recurrence of cancer. Drugs used in
      chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination
      chemotherapy may be a more effective treatment for mantle cell lymphoma.

      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2
      after combination chemotherapy works in treating patients with relapsed or de novo stage II,
      stage III, or stage IV mantle cell lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed mantle cell lymphoma

               -  Stage II, III, or IV disease

               -  Relapsed or de novo disease

          -  No symptomatic brain metastasis

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  White blood count (WBC) > 3,000/mm^3

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hematocrit > 25%

          -  Hemoglobin > 8 g/dL

        Hepatic

          -  Bilirubin < 2.0 mg/dL

        Renal

          -  Creatinine < 2.0 mg/dL OR

          -  Creatinine clearance > 60 mL/min

        Immunologic

          -  No serious ongoing infection

          -  No known HIV infection

          -  No other pre-existing immunodeficiency condition

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception for 1 month before, during, and for
             3 months after study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No other concurrent immunotherapy

        Chemotherapy

          -  More than 4 weeks since prior chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  More than 4 weeks since prior steroids

          -  No concurrent corticosteroids except as replacement doses in patients who are
             hypoadrenal

        Radiotherapy

          -  More than 2 weeks since prior radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  Not specified

        Other

          -  No other concurrent immunosuppressive therapy