The purpose of this study was to determine if an idiotype vaccine, made from a patient's lymphoma that has returned after chemotherapy and/or rituximab, would be able to shrink their tumor.

Condition	Treatment or Intervention	Phase
Lymphoma, Low-Grade	Vaccine: FavId (Id-KLH) active immunotherapy	Phase II

Further Study Details: 

Expected Total Enrollment:  22

The purpose of this study was to assess the ability of active immunotherapy to induce tumor regressions in relapsed low-grade lymphoma. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in the production of immunoglobulin idiotype. B-cell lymphomas arise from the clonal expansion of a single B-cell and all tumor cells express that unique Id protein. No normal B-cells possess that Id on their cell surface. Hence, Id protein should serve as an ideal target for individualized active immune therapy of NHL. Many of the antigens expressed by tumors (including Id) are only weak immunogens. To augment the immune response against Id, the Id protein must be chemically coupled to a strongly immunogenic protein. Keyhole limpet hemocyanin (KLH) is a commonly used protein carrier capable of augmenting the body's immune reaction against Id protein. While initial studies reported a predominately humoral (antibody) response, cellular immunity (T-cells) also plays a critical role in anti-tumor immunity. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• 18 years of age
• Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)
• Patients that have responded with at least stable disease to their most recent chemo- or anti-CD20 antibody (Rituxan®, Zevalin, Bexxar) therapy for a minimum of 90 days and who currently have relapsed or who continue to have stable disease.
• Tumor accessible for biopsy or previously existing biopsy material
• At least 1 additional bidimensional lesion measuring at least 2 cm in each dimension
• Performance status (ECOG) of 0, 1 or 2
• Absolute Granulocyte count ? 1,000/mm3
• Total Bilirubin < 2 mg/dL
• AST and ALT < 2x Upper Limit of Normal
• Creatinine < 1.5 mg/dL

Exclusion Criteria

• Patients who have had more than 3 prior chemotherapy or anti-CD20 regimens
• Prior fludarabine
• Prior tumor-specific idiotype immunotherapy
• Patients whose disease has progressed within the first 90 days of their last chemotherapy or anti-CD20 treatment
• Concurrent immunosuppressive therapy (high-dose steroids; etc)
• Prior splenectomy
• Surgery, cancer radiotherapy, steroid therapy, immunotherapy or chemotherapy within 90 days prior to first scheduled vaccination
• Known history of CNS lymphoma or meningeal lymphomatosis
• HIV positive
• Serious non-malignant disease (e.g., psychiatric disorders, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions which, in the opinion of the investigator would compromise protocol objectives
• Prior malignancy (excluding nonmelanoma carcinomas of the skin and in situ cervical carcinomas) unless in remission for > 2 years
• Treatment with an investigational drug within 30 days prior to study entry
• Pregnant or nursing women NOTE: Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with FavId.

California
      Oncology Associates of San Diego, San Diego,  California,  92123,  United States
      Medical Group of North County, Vista,  California,  92083,  United States
      University of California San Diego, La Jolla,  California,  92093,  United States
      Scripps Stevens Cancer Center, La Jolla,  California,  92037,  United States
      Tower Hematology Oncology Medical Group, Los Angeles,  California,  90048,  United States
Florida
      University of Florida, Jacksonville, Jacksonville,  Florida,  32209,  United States
Illinois
      Northwestern University, Chicago,  Illinois,  60611,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
New York
      New York Hospital - Cornell Medical Center, New York,  New York,  10021,  United States
      New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer Center, Bronx,  New York,  10466,  United States
Ohio
      Oncology Hematology Care, Inc., Cincinnati,  Ohio,  45219,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

Study ID Numbers:  FavId-01
Record last reviewed:  October 2004
Last Updated:  October 26, 2004
Record first received:  May 9, 2002
ClinicalTrials.gov Identifier:  NCT00036426
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08