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Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Low-Grade

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Trial Information

Phase II Study of FavId (Tumor-Specific Idiotype-KLH) and Soluble GM-CSF Immunotherapy in Patients With Stable or Progressive Grade 1 and 2 Follicular B-Cell Lymphomas


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

FavId-01

NCT ID:

NCT00036426

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lymphoma, Low-Grade
  • lymphoma
  • vaccine
  • idiotype
  • KLH
  • GM-CSF
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Henry Ford HospitalDetroit, Michigan  48202
University of California San DiegoLa Jolla, California  92093
Tower Hematology Oncology Medical GroupLos Angeles, California  90048
Northwestern UniversityChicago, Illinois  60611
Scripps Stevens Cancer CenterLa Jolla, California  92037
Oncology Associates of San DiegoSan Diego, California  92123
Medical Group of North CountyVista, California  92083
University of Florida, JacksonvilleJacksonville, Florida  32209
New York Medical College - Our Lady of Mercy Medical Center, Comprehensive Cancer CenterBronx, New York  10466
New York Hospital - Cornell Medical CenterNew York, New York  10021
Oncology Hematology Care, Inc.Cincinnati, Ohio  45219