|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001572 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Vaccination of Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | July 1999 |
| Estimated Primary Completion Date: | July 1999 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
| Study ID Numbers: | 970077, 97-C-0077 |
| Study First Received: | November 3, 1999 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00001572 History of Changes |
| Health Authority: | United States: Federal Government |
|
B-Cell Lymphoma BCL- 2 Positive Tumor Immunization Induction Chemotherapy Lymphoma Vaccine |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Immunoglobulin Idiotypes Physiological Effects of Drugs Adjuvants, Immunologic Lymphoma, Follicular Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Antibodies QS 21 Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
