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Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hodgkin's antigens-GM-CSF-expressing cell vaccine

adjuvant therapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cell vaccine after initial therapy for Hodgkin lymphoma

Arm Description

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

Outcomes

Primary Outcome Measures

Immunologic Response

Durability of Immunologic Response

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

Safety and Tolerability

Secondary Outcome Measures

Full Information

NCT ID

NCT00478062

First Posted

May 23, 2007

Last Updated

January 31, 2018

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00478062

Brief Title

Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma

Official Title

KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

Poor accrual

Study Start Date

April 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

OBJECTIVES: Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine. Determine the durability of these immunologic responses in these patients. Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses. Determine the safety and tolerability of this vaccine in these patients. OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses. Immunologic responses are serially monitored along with disease status. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cell vaccine after initial therapy for Hodgkin lymphoma

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Hodgkin's antigens-GM-CSF-expressing cell vaccine

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Immunologic Response

Time Frame

9 months

Title

Durability of Immunologic Response

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Safety and Tolerability

Time Frame

After administration of last vaccine at 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yvette L. Kasamon, MD

Organizational Affiliation

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Official's Role

Study Chair

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231-2410

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma

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