Protocol Number: 97-C-0077

Title:

Vaccination of Follicular Lymphomas with Tumor-Derived Immunoglobulin Idiotype

Number:

97-C-0077

Summary:

Patients undergo chemotherapy until remission is obtained, or disease has been stable for two cycles of chemotherapy, or progressive disease develops.

Three to six months after completion of chemotherapy, patients who have achieved complete clinical remission or minimal disease status receive a series of 5 injections (given 1-2 months apart) of a vaccine consisting of 0.5 mg autologous tumor-derived immunoglobulin (Id) conjugated to KLH. The vaccine is administered with subcutaneous QS-21 as an immunological adjuvant.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to bemore effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.

Keyword(s):

B-Cell Lymphoma

BCL- 2 Positive Tumor

Immunization

Induction Chemotherapy

Lymphoma Vaccine

Recruitment Keyword(s):

None

Condition(s):

B Cell Lymphoma

Follicular Lymphoma

Neoplasm

Investigational Drug(s):

Id-KLH Vaccine

Investigational Device(s):

None

Interventions:

Drug: Id-KLH Vaccine

Drug: QS-21 (Stimulation-QS-21) Drug

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Antibody to molecularly defined antigen confined to a tumor cell surface

Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins

Induction of immune responses in patients with B cell lymphoma against the surface immunoglobulin idiotype expressed by their tumors

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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