Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Id-KLH Vaccine
+ QS-21 (Stimulation-QS-21) Drug
Hemic and Lymphatic Diseases+8
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: January 30, 1997
Actual date on which the first participant was enrolled.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 objectives of this study are: 1) to evaluate feasibility and toxicity of new vaccine formulations, and 2) to evaluate cellular and humoral immune responses against the unique idiotype of the patient's lymphoma. The goal of this study is to treat patients with follicular lymphomas to complete remission or minimal residual disease with chemotherapy. Six to twelve months after completion of chemotherapy, in an effort to reduce the relapse rate (by eradicating microscopic disease resistant to chemotherapy), patients will receive one of two new formulations of an autologous Id vaccine.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: Sample size: up to 30 patients. Sex distribution: Male and female. Age: Patients must be greater than or equal to 18 years old. Patients must meet all of the following eligibility criteria: Tissue diagnosis of: follicular small cleaved cell or follicular mixed lymphoma with surface IgM, IgA, or IgG 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. A single peripheral lymph node of at least 2x2 to 3x3 cm size and accessible for biopsy/harvest. Karnofsky status greater than or equal to 70%. Life expectancy of greater than 1 year. Serum creatinine less than or equal to 1.5 mg/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 x 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. There are no gender or racial / ethnic restrictions on patient selection. This protocol is open to all genders and racial / ethnic groups. EXCLUSION CRITERIA: The presence of any exclusion criteria (listed below) will prohibit entry onto study: Prior total body irradiation. Presence of antibodies to HIV or hepatitis B surface antigen or other active infectious process. Pregnant or lactation. Fertile men and women must plan to use an 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. Patient unwilling to give informed consent. Failure to meet any of the eligibility criteria in Section 3.2. Any medical or psychiatric condition that in the opinion of the protocol chairman would compromise the patient's ability to tolerate this treatment. Patients with CNS lymphoma (current or previously treated) will not be eligible.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps