Brain and Central Nervous System TumorsPhase 1NCT00005813
Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme
A Phase 1 study testing bispecific antibody MDX447, lymphokine-activated killer cells and conventional surgery in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. 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?
- bispecific antibody MDX447, lymphokine-activated killer cells and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Jan 2003
- Phase
- Phase 1
- 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 proven glioblastoma multiforme with evidence of epidermal growth factor receptor (EGFR) expression on tumor cell surfaces
- No astrocytoma, anaplastic astrocytoma, or oligodendroglioma
- No infratentorial or multifocal tumor
- Recurrence or progression following at least one prior therapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 2 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- ALT, AST, and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2.0 times ULN
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other medical or psychiatric illness that would preclude study
- No other concurrent malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
Endocrine therapy:
- Concurrent steroid therapy allowed
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
About this study
Official title: A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme
RATIONALE: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.
Read the detailed description
OBJECTIVES:
- Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
- Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.
OUTLINE: This is a dose escalation study.
Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.
Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- bispecific antibody MDX447, lymphokine-activated killer cells, conventional surgery
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- 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.
bispecific antibody MDX447Biological
lymphokine-activated killer cellsBiological
conventional surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2003 (estimated)
- Study startMar 1997
- Primary completionJan 2003
- Study completionJan 2003
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.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Camilo E Fadul, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005813
- Sponsor's protocol ID
- D9705
- Other IDs
- P30CA023108, NCI-G00-1783
- Status last verified
- Oct 2011
- First submitted
- 2 Jun 2000
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00005813
- Acronym / sponsor ID
- D9705
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1997
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 20 May 2003 (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: Bispecific antibodies plus white blood cells may be able to locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of combining bispecific antibodies with white blood cells in treating patients who have recurrent or refractory glioblastoma multiforme.
Detailed description
OBJECTIVES:
- Assess the safety and tolerability of bispecific antibody MDX447 and activated monocytes in patients with recurrent or refractory glioblastoma multiforme.
- Determine the response, time to tumor progression, and overall survival of these patients treated with this regimen.
OUTLINE: This is a dose escalation study.
Patients undergo maximal surgical debulking of the tumor at the time of reservoir placement. Within 2-4 weeks after surgery, patients receive one treatment of intratumoral bispecific antibody MDX447 and activated monocytes. Stable or responding patients may receive a second treatment 1 month later.
Cohorts of 1 or 3 patients receive escalating doses of bispecific antibody MDX447 and activated monocytes until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| bispecific antibody MDX447 | Biological | – |
| lymphokine-activated killer cells | Biological | – |
| conventional surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 27 Oct 2011.
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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.
Camilo E Fadul, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bispecific antibody MDX447, lymphokine-activated killer cells and conventional surgery in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center 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 27 Oct 2011. 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 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.
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.
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 27 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.