Vaccine Therapy Plus Sargramostim Following Chemotherapy in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Vaccines may make the body build an immune response to kill
      cancer cells. Colony-stimulating factors such as sargramostim may increase the number of
      immune cells found in bone marrow or peripheral blood and may help a person's immune system
      recover from the side effects of chemotherapy.

      PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in
      treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a
      specific immune response against the B cell idiotype of the malignant clone that constitutes
      the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II.
      Determine the safety and toxicity of this treatment regimen using Genitope Corporation's
      molecular rescue technology in this patient population.

      OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide, doxorubicin,
      vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone, vincristine, and
      prednisone (CNOP). Treatment repeats every 3 weeks until the maximal clinical response is
      achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 6
      courses. At 2-6 months following completion of chemotherapy, patients achieving adequate
      disease response receive vaccination consisting of recombinant tumor derived immunoglobulin
      idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ) followed by
      sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive GM-CSF alone on
      days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months later by the fifth
      and final dose. Patients are followed every 3 months for 2 years, every 6 months for 2 years,
      and then annually thereafter until disease progression.

      PROJECTED ACCRUAL: Not specified
    

Intervention name(s): keyhole limpet hemocyanin; sargramostim; tumor cell-based vaccine therapy; cyclophosphamide; doxorubicin hydrochloride; mitoxantrone hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Biological; Biological; Biological; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Cytoxan; Lipodox, Lipodox 50, and Doxil; Novantrone; Prednisone Intensol, Deltasone, Rayos; Kyocristine, Vincrisul, Onkovin
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vincristine; Mitoxantrone; Sargramostim; Keyhole-limpet hemocyanin; Vaccines
Primary purpose: Treatment
Keywords: stage I grade 3 follicular lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage I mantle cell lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III mantle cell lymphoma; stage IV mantle cell lymphoma