Brain and Central Nervous System TumorsPhase 2NCT00814593
Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery
A Phase 2 study testing lymphokine-activated killer cells and polifeprosan 20 with carmustine implant in people with Brain and Central Nervous System Tumors, run by Lisata Therapeutics, Inc. at 1 site in United States.
Trial summary
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors
- What is being tested?
- lymphokine-activated killer cells and polifeprosan 20 with carmustine implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary malignant glioblastoma multiforme (GBM) (i.e., grade IV anaplastic astrocytoma)
- Must have undergone standard primary therapy (e.g., surgery, radiotherapy, and temozolomide) within the past 90 days
- Additional anticancer therapy as part of first-line therapy, including a radiosurgical procedure (e.g., stereotactic or gamma knife radiosurgery) allowed
- Must be an operable candidate and willing to undergo craniotomy
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 2 months
- Hemoglobin > 10.0 g/dL
- AGC > 1,500/mm³
- Platelet count > 100,000/mm³
- Serum total bilirubin < 1.5 times upper limit of normal (ULN)
- ALT and AST < 2.5 times ULN
- Serum creatinine < 1.5 times ULN
- Negative pregnancy test
- Resides in the United States of America
- Venous access available for leukapheresis procedure to obtain peripheral blood mononuclear cells
- No diagnosis of any other invasive cancer within the past 5 years, except in situ carcinoma or basal cell carcinoma or localized squamous cell carcinoma of the skin
- Patients with prior diagnosis of minimal microscopic cancer (e.g., colonic polyp or stage I prostate cancer with Gleason score < 6) may be eligible, as determined by the principal investigator
- No concurrent serious medical or psychiatric illness that may interfere with giving informed consent or conducting this study
- No known hypersensitivity or allergy to either carmustine or aldesleukin
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior anticancer therapy and recovered
- No polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of prior surgery for GBM
- No prior treatment for progressive disease
- No other concurrent anticancer therapy (e.g., continuation of hormonal therapy for breast or prostate cancer that was diagnosed > 5 years ago)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoag Cancer Institute at Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
Official title: Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating patients with glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying the side effects and how well lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with newly diagnosed glioblastoma multiforme that can be removed by surgery.
Read the detailed description
OBJECTIVES:
- To compare the side effects, including infections and/or abnormal healing at the surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for patients with newly diagnosed resectable glioblastoma multiforme.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: Patients are stratified according to age (< 50 vs ≥ 50 years of age), Karnofsky performance status (70-80% vs 90-100%), use of corticosteroids > 4 mg/day (yes vs no), and progressive disease during first-line therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
- Arm II: Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.
After completion of study treatment, patients are followed periodically for up to 5 years.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- lymphokine-activated killer cells, polifeprosan 20 with carmustine implant
- Keywords
- adult giant cell glioblastoma, adult gliosarcoma, adult 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.
lymphokine-activated killer cellsBiological
Instilled into the tumor bed cavity
polifeprosan 20 with carmustine implantDrug
Intracranial placement
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy. Receives: Drug: polifeprosan 20 with carmustine implant |
| Arm II | Experimental | Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy. Receives: Biological: lymphokine-activated killer cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years or death, whichever came first.
Secondary outcomes (3)
Rate of significant surgical wound infection (grade 3 or 4)
Measured: 4 weeks from date of study treatment.
Rate of grade 3 or 4 non-infectious wound complications
Measured: 4 weeks from date of study treatment.
Toxicity as assessed by NCI CTCAE version 3.0
Measured: 4 weeks from date of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2011
- Study completionSep 2011
Why it stopped: Hoag Hospital ceased support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisata Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert O. Dillman, MD, FACP, Principal investigator, Caladrius Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814593
- Sponsor's protocol ID
- CDR0000630437
- Other IDs
- HOAG-HCC-08-01
- Status last verified
- May 2019
- First submitted
- 24 Dec 2008
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma
- ClinicalTrials.gov ID
- NCT00814593
- Acronym / sponsor ID
- CDR0000630437
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult giant cell glioblastoma, adult gliosarcoma, adult glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Hoag Hospital ceased support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lisata Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Dec 2008 (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 lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating patients with glioblastoma multiforme.
PURPOSE: This randomized phase II trial is studying the side effects and how well lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with newly diagnosed glioblastoma multiforme that can be removed by surgery.
Detailed description
OBJECTIVES:
- To compare the side effects, including infections and/or abnormal healing at the surgery site, associated with intralesional lymphokine-activated killer (LAK) cells vs polifeprosan 20 with carmustine implant (Gliadel® wafer) as consolidation therapy for patients with newly diagnosed resectable glioblastoma multiforme.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: Patients are stratified according to age (< 50 vs ≥ 50 years of age), Karnofsky performance status (70-80% vs 90-100%), use of corticosteroids > 4 mg/day (yes vs no), and progressive disease during first-line therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy.
- Arm II: Patients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy.
After completion of study treatment, patients are followed periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: polifeprosan 20 with carmustine implantPatients undergo intracranial placement of polifeprosan 20 with carmustine implant (Gliadel® wafer) at the time of therapeutic craniotomy. |
| Arm II | Experimental | Biological: lymphokine-activated killer cellsPatients undergo leukapheresis to obtain autologous lymphokine-activated killer (LAK) cells, followed 3-7 days later by therapeutic craniotomy. The autologous LAK cells are then instilled into the tumor bed cavity at the time of therapeutic craniotomy. |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| lymphokine-activated killer cellsInstilled into the tumor bed cavity | Biological | Arm II |
| polifeprosan 20 with carmustine implantIntracranial placement | Drug | Arm I |
Primary outcome
Overall survival
Time frame: 5 years or death, whichever came first.
3 secondary outcomes
Rate of significant surgical wound infection (grade 3 or 4)
Time frame: 4 weeks from date of study treatment.
Rate of grade 3 or 4 non-infectious wound complications
Time frame: 4 weeks from date of study treatment.
Toxicity as assessed by NCI CTCAE version 3.0
Time frame: 4 weeks from date of study treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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 principal investigator
Caladrius Biosciences
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 lymphokine-activated killer cells and polifeprosan 20 with carmustine implant in people with Brain and Central Nervous System Tumors, run by Lisata Therapeutics, Inc. 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: withdrawn, as of the sponsor's last update on 10 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Overall survival (time frame: 5 years or death, whichever came first.). 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 10 May 2019.