Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Completed · Phase 1

Conditions studied: B Cell Lymphoma, Follicular Lymphoma, Neoplasm

In brief

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....

Key facts

Study ID

NCT00001572

Run by

National Cancer Institute (NCI)

People needed

21

Starts

1997-01-30

Expected to finish

2010-11-02

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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