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Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

Primary Purpose

B Cell Lymphoma, Follicular Lymphoma, Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Id-KLH Vaccine
QS-21 (Stimulation-QS-21) Drug
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma focused on measuring B-Cell Lymphoma, BCL- 2 Positive Tumor, Immunization, Induction Chemotherapy, Lymphoma Vaccine, Follicular Lymphoma, Tumor-Derived Immunoglobulin Idiotype

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001572
Brief Title
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Official Title
Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype
Study Type
Interventional

2. Study Status

Record Verification Date
November 2, 2010
Overall Recruitment Status
Completed
Study Start Date
January 30, 1997 (undefined)
Primary Completion Date
July 31, 1999 (Actual)
Study Completion Date
November 2, 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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....
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma, Follicular Lymphoma, Neoplasm
Keywords
B-Cell Lymphoma, BCL- 2 Positive Tumor, Immunization, Induction Chemotherapy, Lymphoma Vaccine, Follicular Lymphoma, Tumor-Derived Immunoglobulin Idiotype

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Id-KLH Vaccine
Intervention Type
Drug
Intervention Name(s)
QS-21 (Stimulation-QS-21) Drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
47617
Citation
Stevenson GT, Stevenson FK. Antibody to a molecularly-defined antigen confined to a tumour cell surface. Nature. 1975 Apr 24;254(5502):714-6. doi: 10.1038/254714a0. No abstract available.
Results Reference
background
PubMed Identifier
4108872
Citation
Sirisinha S, Eisen HN. Autoimmune-like antibodies to the ligand-binding sites of myeloma proteins. Proc Natl Acad Sci U S A. 1971 Dec;68(12):3130-5. doi: 10.1073/pnas.68.12.3130.
Results Reference
background
PubMed Identifier
1406793
Citation
Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. Induction of immune responses in patients with B-cell lymphoma against the surface-immunoglobulin idiotype expressed by their tumors. N Engl J Med. 1992 Oct 22;327(17):1209-15. doi: 10.1056/NEJM199210223271705.
Results Reference
background

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Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype

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