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.

Condition	Treatment or Intervention	Phase
B Cell Lymphoma Follicular Lymphoma Neoplasm	Drug: Id-KLH Vaccine  Drug: QS-21 (Stimulation-QS-21) Drug	Phase I

Further Study Details: 

Expected Total Enrollment:  30

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.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Sex: 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.
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 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:
The presence of any exclusion criteria listed below will prohibit entry onto protocol:
Prior total body irradiation.
Presence of antibodies to HIV or hepatitis B surface agents or other active infectious process.
Pregnant or lactating. 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.
Patients unwilling to give informed consent.
Any medical or psychiatric condition that in the opinion of the protocot chairman would compromise the patient's ability to tolerate treatment.
Patients with CNS lymphoma (current or previously treated) will not be eligible.

Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

Study ID Numbers:  970077; 97-C-0077
Record last reviewed:  January 1, 2005
Last Updated:  January 4, 2005
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001572
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08