Completed

Phase 1
Age: 18Years +
All Genders
ID00001572

Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Led by National Cancer Institute (NCI) · Updated on 2017-07-02

21

Participants Needed

1

Research Sites

587 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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....

CONDITIONS

Official Title

Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States, 20892

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors.

L W Kwak, M J Campbell, D K Czerwinski...

https://pubmed.ncbi.nlm.nih.gov/1406793