Physician Information

There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe. There are many subtypes of Non-Hodgkin’s Lymphoma including B-cell and T-cell, indolent , aggressive and highly aggressive. Despite the use of aggressive chemotherapy and recent advances in therapy such as monoclonal antibodies (Rituxan), the indolent B-cell form of the disease is not considered curable. The median relapse time for indolent follicular Non-Hodgkin’s Lymphoma patients is three years. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy. Related B-cell derived neoplasms include multiple myeloma (approx. 15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in the US).

The BiovaxID™ cancer immunotherapy stems from work begun in 1986 on development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of each patient's immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. In the vaccine's cancer target, indolent follicular B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen on the cancer cells that is not present in non-cancerous cells. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces an immune response against the cancerous cells and creates an immune memory. Because BiovaxID™ is derived from individual patient's cancerous cells, the vaccine is a true targeted, customized therapy. The vaccine's anti-tumor effect is different than that of non-targeted traditional therapies, as it arises from the immune system's defense cells' innate ability to selectively target foreign antigens. And importantly, the immune response triggered by the vaccine against the cancerous tissue is a natural disease-fighting mechanism and appears to be associated with minimal toxicity.

 

Study Parameters for the BiovaxID™ Phase 3 Clinical Trial

If you wish to enroll or have additional questions regarding this clinical trial, please contact us toll-free at 877-654-6052 or visit our Clinical Trials Center.

Phase III Protocol

Phase III Randomized Study of Keyhole Limpet Hemocyanin and Sargramostim (GM-CSF) With or Without Autologous Lymphoma-Derived Idiotype-Specific Vaccination After Standard Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone in Patients With Stage II-IV Follicular Lymphoma

• Date Last Modified: 2004-07-06
• Date First Published: 2000-02-01

Basic Study Information

Phase of Trial	Type of Trial	Status of Trial	Age Range (yrs.)	Sponsor of Trial	Protocol IDs
Phase 3	Treatment	Active	18 and over	Biovest/Accentia	BV#301

Objectives

• Determine the impact of autologous lymphoma-derived idiotype-specific vaccination (Id vaccine) on the disease-free survival (DFS) of patients with stage II-IV follicular lymphoma who achieve first complete remission (CR) after standard cyclophosphamide, doxorubicin, etoposide, and prednisone.
• Determine the ability of Id vaccine to produce a molecular CR in patients with a clinical CR but with polymerase chain reaction evidence of residual disease after standard chemotherapy.
• Determine the impact of Id vaccine on molecular DFS in these patients.
• Assess the ability of Id vaccine to generate an immunologic response against autologous tumor in these patients
• Compare the overall survival of patients with CR after standard chemotherapy who are then treated with keyhole limpet hemocyanin and sargramostim (GM-CSF) with or without Id vaccine.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage II-IV follicular center cell lymphoma
  • Small cleaved cell, mixed cell, or large cell with centrocytes
  • Surface IgM or IgG phenotype with monoclonal heavy and light chain by flow cytometry
  • Grade I-IIIa
• Stage II disease must have bulky adenopathy (greater than 5 cm in diameter)
• Must have one of the following as a source of lymphoma cells for vaccine production:
  • Single peripheral lymph node that is greater than 2 cm and accessible for biopsy/harvest
  • Single abdominal lymph node that is greater than 2 cm and accessible for laparoscopic biopsy
  • Lymphoma cells circulating in peripheral blood, malignant pleural effusion, or malignant ascites if adequate number of cells (more than 109) are present
• No prior or concurrent primary or secondary CNS lymphoma

Determine the impact of autologous lymphoma-derived idiotype-specific vaccination (Id vaccine) on the disease-f

Prior/Concurrent Therapy:

Biologic therapy:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent dexamethasone
• Prior prednisone for no more than 2 months duration allowed
• Concurrent steroids for no more than 2 weeks duration for an unrelated medical condition allowed

Radiotherapy:

• Prior radiotherapy to 1 or 2 sites allowed
• No prior total body irradiation
• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent therapy for lymphoma
• Concurrent nonsteroidal anti-inflammatory drugs for no more than 2 weeks duration for an unrelated medical condition allowed

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-1 (unless directly related to lymphoma)

Life expectancy:

• More than 1 year

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 mg/dL (unless due to lymphoma or Gilbert's disease)
• SGOT/SGPT no greater than 3.5 times upper limit of normal
• Hepatitis B surface antigen negative

Renal:

• Creatinine no greater than 1.5 mg/dL (unless due to lymphoma)

Other:

• HIV negative
• Not pregnant or nursing