Status:
COMPLETED
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
B Cell Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 chemothe...
Detailed Description
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 fo...
Eligibility 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.
Key Trial Info
Start Date :
January 30 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00001572
Start Date
January 30 1997
End Date
November 2 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892