LymphomaPhase 1/2NCT00478062
Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
A Phase 1/2 study testing Hodgkin's antigens-GM-CSF-expressing cell vaccine and adjuvant therapy in people with Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Hodgkin's antigens-GM-CSF-expressing cell vaccine and adjuvant therapy
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2008
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- Hodgkin's antigens-GM-CSF-expressing cell vaccine, adjuvant therapy
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hodgkin's antigens-GM-CSF-expressing cell vaccineBiological
adjuvant therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cell vaccine after initial therapy for Hodgkin lymphoma | Experimental | Hodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. Receives: Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine; Procedure: adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic Response
Measured: 9 months
Durability of Immunologic Response
Measured: 2 years
Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
Measured: 2 years
Safety and Tolerability
Measured: After administration of last vaccine at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yvette L. Kasamon, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478062
- Sponsor's protocol ID
- J06143 CDR0000544408
- Other IDs
- P50CA096888, P30CA006973, JHOC-J06143, JHOC-NA_00007920
- Status last verified
- Oct 2016
- First submitted
- 23 May 2007
- Last updated
- 28 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00478062
- Acronym / sponsor ID
- J06143 CDR0000544408
- Conditions
- Lymphoma
- Keywords
- stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 28 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell vaccine after initial therapy for Hodgkin lymphoma | Experimental | Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine, Procedure: adjuvant therapyHodgkin's antigens-GM-CSF-expressing cell vaccine after initial therapy. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hodgkin's antigens-GM-CSF-expressing cell vaccine | Biological | Cell vaccine after initial therapy for Hodgkin lymphoma |
| adjuvant therapy | Procedure or surgery | Cell vaccine after initial therapy for Hodgkin lymphoma |
Primary outcome
Immunologic Response
Time frame: 9 months
Durability of Immunologic Response
Time frame: 2 years
Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
Time frame: 2 years
Safety and Tolerability
Time frame: After administration of last vaccine at 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvette L. Kasamon, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hodgkin's antigens-GM-CSF-expressing cell vaccine and adjuvant therapy in people with Lymphoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunologic Response (time frame: 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.