NCT00001572

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 1997

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
11 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2010

Completed
Last Updated

July 2, 2017

Status Verified

November 2, 2010

Enrollment Period

2.5 years

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

B Cell LymphomaFollicular LymphomaNeoplasm

Keywords

B-Cell LymphomaBCL- 2 Positive TumorImmunizationInduction ChemotherapyLymphoma VaccineFollicular LymphomaTumor-Derived Immunoglobulin Idiotype

Interventions

Id-KLH VaccineDRUG
QS-21 (Stimulation-QS-21) DrugDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 47617BACKGROUND

  • 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.

    PMID: 4108872BACKGROUND

  • 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.

    PMID: 1406793BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, FollicularNeoplasms

Interventions

saponin QA-21V1Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

January 30, 1997

Primary Completion

July 31, 1999

Study Completion

November 2, 2010

Last Updated

July 2, 2017

Record last verified: 2010-11-02

Locations

US(1)