Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Favrille.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Favrille
ClinicalTrials.gov Identifier:
NCT00036426
First received: May 9, 2002
Last updated: June 23, 2005
Last verified: October 2004

May 9, 2002
June 23, 2005
March 2001
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Complete list of historical versions of study NCT00036426 on ClinicalTrials.gov Archive Site
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Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma
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 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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Low-Grade
Biological: FavId (Id-KLH) active immunotherapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036426
FavId-01
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Favrille
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Favrille
October 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP