NCT00478062

Brief Summary

RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 lymphoma

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

May 23, 2007

Results QC Date

January 31, 2018

Last Update Submit

January 31, 2018

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (4)

  • Immunologic Response

    9 months

  • Durability of Immunologic Response

    2 years

  • Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses

    2 years

  • Safety and Tolerability

    After administration of last vaccine at 9 weeks

Study Arms (1)

Cell vaccine after initial therapy for Hodgkin lymphoma

EXPERIMENTAL

Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.

Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccineProcedure: adjuvant therapy

Interventions

Hodgkin's antigens-GM-CSF-expressing cell vaccineBIOLOGICAL
Cell vaccine after initial therapy for Hodgkin lymphoma
adjuvant therapyPROCEDURE
Cell vaccine after initial therapy for Hodgkin lymphoma

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of classic Hodgkin's lymphoma * Must have completed first-line therapy without evidence of disease progression PATIENT CHARACTERISTICS: * HIV negative PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 6 months since prior chemotherapy or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Results Point of Contact

Title
Yvette Kasamon
Organization
Johns Hopkins Sidney Kimmel Cancer Center
ykasamon@jhmi.edu
4109135018

Study Officials

  • Yvette L. Kasamon, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 28, 2018

Results First Posted

February 28, 2018

Record last verified: 2016-10

Locations

US(1)