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

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00478062
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 14
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine; Procedure: adjuvant therapy	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cell vaccine after initial therapy for Hodgkin lymphoma Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy.	Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine; Procedure: adjuvant therapy

Outcome Measures

Primary Outcome Measures

1. Immunologic Response [9 months]

2. Durability of Immunologic Response [2 years]

3. Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses [2 years]

4. Safety and Tolerability [After administration of last vaccine at 9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Study Chair: Yvette L. Kasamon, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00478062
• Other Study ID Numbers: J06143 CDR0000544408; P50CA096888; P30CA006973; JHOC-J06143; JHOC-NA_00007920
• First Posted: May 24, 2007
• Last Update Posted: Feb 28, 2018
• Last Verified: Oct 1, 2016

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease

Study Results

Participant Flow

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%

Outcome Measures

1. Primary Outcome

Title	Immunologic Response
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Measure Participants	0

2. Primary Outcome

Title	Durability of Immunologic Response
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Measure Participants	0

3. Primary Outcome

Title	Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Measure Participants	0

4. Primary Outcome

Title	Safety and Tolerability
Time Frame	After administration of last vaccine at 9 weeks

Outcome Measure Data

Analysis Population Description

The study was closed due to slow accrual, with only one patient enrolled. No data was analyzed for any outcome measures.

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
Measure Participants	0

Adverse Events

Arm/Group Title	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
Arm/Group Description	Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Hodgkin's antigens-GM-CSF-expressing cell vaccine adjuvant therapy
All Cause Mortality
	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Serious Adverse Events
	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Cell Vaccine After Initial Therapy for Hodgkin Lymphoma
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.