Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

The idiotype of the immunoglobulin on a given B cell malignancy (Id) can serve as a clonal marker, and a previous pilot study in lymphoma patients has demonstrated that autologous Id protein can be formulated into an immunogenic, tumor specific antigen by conjugation to a carrier protein (KLH) and administration with an emulsion-based adjuvant. The goals of vaccine development in the current study are to develop vaccines: 1) with improved potency and 2) which are more effective at inducing cell-mediated immune responses. The selection of GM-CSF as the immunological "adjuvant" is a direct ex...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Patients must meet all of the following eligibility criteria.
• • Tissue diagnosis of: follicular small cleaved cell, or follicular mixed lymphoma with surface IgM, IgG or IgA phenotype with a monoclonal heavy and light chain. Pathology slides must be submitted to the NIH Pathology Department for review.
• • Stage III or IV lymphoma.
• • Only previously untreated patients are eligible.
• • Previous treatment with radiation alone (less than TBI) is permissible.
• • A single peripheral lymph node of at least 2 cm size accessible for biopsy/harvest.
• • Karnofsky status greater than or equal to 70 percent.
• • Life expectancy of greater than 1 year.
• • Serum creatinine less than or equal to 1.5 mg per dl unless felt to be secondary to lymphoma.
• • Bilirubin less than or equal to 1.5 mg/dl unless felt to be secondary to lymphoma or Gilbert's disease. SGOT/SGPT less than or equal to 3.5 times upper limit of normal.
• • Ability to give informed consent. Ability to return to clinic for adequate follow-up for the period that the protocol requires.
• EXCLUSION CRITERIA:
• • Prior total body irradiation.
• • Presence of antibodies to HIV, hepatitis B surface antigen or other active infectious process.
• • Pregnancy or lactation. Fertile men and women must plan to use effective contraception. A beta-HCG level will be obtained in women of child-bearing potential.
• • Patients with previous or concomitant malignancy, regardless of site, except curatively treated squamous or basal cell carcinoma of the skin, or effectively treated carcinoma in situ of the cervix.
• • Patients unwilling to give informed consent.
• • Failure to meet any of the inclusion criteria.
• • Any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment will be excluded from this protocol.
• • Patient with CNS lymphoma (current or previously treated) will not be eligible.