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Immunoglobulin Idiotypes

Id-KLH

The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.

The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype. Secondary objectives are the determination of overall objective response rate, duration of response and time to progression. B-cell malignancies express a unique antigen, the immunoglobulin idiotype (Id), on their surface. Each B-cell harbors a unique genetic sequence used in production of 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. For vaccines which produce primarily an antibody response, there is a concern that combining immunotherapy with Rituxan®, which produces a rapid and sustained (up to 6 to 9 months post-treatment in 83% of patients) depletion of circulating and tissue-based B-cells, would blunt any antibody response. For vaccines that induce strong T-cell responses like Id-KLH plus GM-CSF, there is evidence in mice that depleting the host of B-cells could actually increase the T-cell response to the vaccine. GM-CSF is a hematopoietic growth factor that stimulates T-cell proliferation. T-cell response to both the patient's Idiotype and KLH will be measured during this trial.

Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma

Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma

Favrille

Lymphoma, Follicular

Follicular Lymphoma

5 monthly vaccinations over a 6 month time period consisting of 0.5 mg ID-KLH s.c. on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4

FNHLId1

5 monthly vaccinations at month 1, 2, 3, 4, and 6 consisting of 0.5 mg KLH s.c on day 1 and 100 mcg/m²/day GM-CSF s.c. on days 1-4

KLH + GM-CSF

Carlos F Santos, PhD

Stephen J Schuster, MD

The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.

Patients with Stage III-IV follicular lymphoma and tumor \> 2cm (Stage II allowed if tumor \> 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.

Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma

Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

Biovest International

Immunologic Factors

FavId (Id-KLH) active immunotherapy

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma	NCT00041730	Non-Hodgkin's L...	Id-KLH	18 Years -	Favrille
Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma	NCT00091676	Non-Hodgkins Ly...	FNHLId1 KLH + GM-CSF	18 Years -	Biovest International
Idiotype Vaccine for Low-Grade Non-Hodgkin's Lymphoma	NCT00036426	Lymphoma, Low-G...	FavId (Id-KLH) ...	18 Years -	Favrille

Spots Global Cancer Trial Database for idiotype

Every month we try and update this database with for idiotype cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for idiotype

Every month we try and update this database with for idiotype cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for idiotype cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.