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Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001572
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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 Intervention Phase
B Cell Lymphoma Follicular Lymphoma Neoplasm Drug: Id-KLH Vaccine Drug: QS-21 (Stimulation-QS-21) Drug Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 21
Study Start Date: January 30, 1997
Study Completion Date: November 2, 2010
Primary Completion Date: July 31, 1999 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001572


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001572     History of Changes
Obsolete Identifiers: NCT00878410
Other Study ID Numbers: 970077
97-C-0077
First Submitted: November 3, 1999
First Posted: November 4, 1999
Last Update Posted: July 2, 2017
Last Verified: November 2, 2010

Keywords provided by National Institutes of Health Clinical Center (CC):
B-Cell Lymphoma
BCL- 2 Positive Tumor
Immunization
Induction Chemotherapy
Lymphoma Vaccine
Follicular Lymphoma
Tumor-Derived Immunoglobulin Idiotype

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vaccines
Immunoglobulins
Antibodies
QS 21
Immunoglobulin Idiotypes
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic