Brain and Central Nervous System TumorsPhase 2NCT00331526
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
A Phase 2 study testing aldesleukin, therapeutic autologous lymphocytes and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Hoag Memorial Hospital Presbyterian at 1 site in United States.
Trial summary
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- aldesleukin, therapeutic autologous lymphocytes and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of primary malignant glioblastoma multiforme (i.e., grade IV anaplastic astrocytoma)
- Primary treatment (surgery, radiation, and/or chemotherapy) has been completed
- Candidate for surgery and willing to undergo craniotomy
- No progressive or recurrent disease
- No residual disease that requires reoperation, additional gamma therapy, or other modality
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 70-100% (i.e., if symptomatic, bedridden < half of a waking day)
- Life expectancy ≥ 2 months
- Not pregnant
- Negative pregnancy test
- U.S. residents only
- No hematopoietic, hepatic, renal, cardiovascular, or pulmonary laboratory values or other medical circumstances that would preclude surgery or aldesleukin therapy
- No serious concurrent medical or psychiatric illness that would preclude informed consent or study treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior anticancer therapy and recovered
- Prior stereotactic or gamma knife radiosurgery allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
- Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme.
- Determine progression-free and overall survival of these patients.
- Compare survival of these patients to that of contemporary and historical controls.
OUTLINE: Patients undergo therapeutic craniotomy.
Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- aldesleukin, therapeutic autologous lymphocytes, adjuvant therapy, conventional surgery
- Keywords
- adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma
- Medical subject headings
- Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
therapeutic autologous lymphocytesBiological
adjuvant therapyProcedure or surgery
conventional surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects and toxicity
Progression-free survival and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2006 (estimated)
- Study startFeb 1999
- Primary completionDec 2008
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoag Memorial Hospital Presbyterian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert O. Dillman, MD, FACP, Study chair, Hoag Memorial Hospital Presbyterian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331526
- Sponsor's protocol ID
- CDR0000471241
- Other IDs
- HOAG-CBRG-98-09
- Status last verified
- Mar 2013
- First submitted
- 30 May 2006
- Last updated
- 25 Mar 2013
- Results posted
- No
Publications
Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother. 2009 Nov-Dec;32(9):914-9. doi: 10.1097/CJI.0b013e3181b2910f.
PubMed 19816190
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Intralesional Adoptive Cellular Therapy of Glioblastoma With Interleukin-2-Stimulated Lymphocytes
- ClinicalTrials.gov ID
- NCT00331526
- Acronym / sponsor ID
- CDR0000471241
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hoag Memorial Hospital PresbyterianUniversity, hospital or other
- Study start
- Feb 1999
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 31 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells, including lymphokine-activated killer cells, to kill tumor cells. Giving cellular adoptive immunotherapy during or after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well cellular adoptive immunotherapy works in treating patients with glioblastoma multiforme.
Detailed description
OBJECTIVES:
- Determine the feasibility, side effects, and toxicity associated with intracranial cellular adoptive immunotherapy comprising aldesleukin-stimulated lymphokine-activated killer cells in patients with glioblastoma multiforme.
- Determine progression-free and overall survival of these patients.
- Compare survival of these patients to that of contemporary and historical controls.
OUTLINE: Patients undergo therapeutic craniotomy.
Patients undergo leukapheresis to obtain lymphokine-activated killer (LAK) cells 3-7 days before therapeutic craniotomy OR 4-6 weeks after therapeutic craniotomy. Patients receive cellular adoptive immunotherapy comprising aldesleukin-stimulated LAK cells intracranially at the time of therapeutic craniotomy OR via an Ommaya reservoir (placed during craniotomy) no sooner than 4-6 weeks after therapeutic craniotomy.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| aldesleukin | Biological | – |
| therapeutic autologous lymphocytes | Biological | – |
| adjuvant therapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Side effects and toxicity
Progression-free survival and overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Results publication: PubMed 19816190Dillman RO, Duma CM, Ellis RA, Cornforth AN, Schiltz PM, Sharp SL, DePriest MC. Intralesional lymphokine-activated killer cells as adjuvant therapy for primary glioblastoma. J Immunother. 2009 Nov-Dec;32(9):914-9. doi: 10.1097/CJI.0b013e3181b2910f.
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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.
Robert O. Dillman, MD, FACP study chair
Hoag Memorial Hospital Presbyterian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin, therapeutic autologous lymphocytes and adjuvant therapy in people with Brain and Central Nervous System Tumors, run by Hoag Memorial Hospital Presbyterian 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: finished, as of the sponsor's last update on 25 Mar 2013. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Side effects and toxicity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00331526, which also lists 1 linked publication.
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 25 Mar 2013.