Brain and Central Nervous System TumorsPhase 2NCT00004017
Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
A Phase 2 study testing conventional surgery and iodine I 131 monoclonal antibody TNT-1/B in people with Brain and Central Nervous System Tumors, run by Peregrine Pharmaceuticals at 4 sites in United States.
Trial summary
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors. 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?
- conventional surgery and iodine I 131 monoclonal antibody TNT-1/B
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2000to not given
- 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 newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma (AA)
- MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no greater than 60 cm^3
- Recurrent GBM and AA must be documented by MRI after the most recent treatment and before any planned surgical debulking
- At least 5 days since prior surgical debulking
- No planned resection of newly diagnosed GBM before or during study
- No bilateral noncontiguous gadolinium enhancing tumors
- No satellite lesions greater than 1.5 cm from anticipated location of interstitial catheter tip
- No more than 2 satellite lesions
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- WBC at least 3,000/mm^3
Hepatic:
- Hepatitis B surface antigen negative
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
- Lactic dehydrogenase no greater than 3 times ULN
- Prothrombin time no greater than 1.5 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No significant unstable cardiovascular disease
- No New York Heart Association class III/IV heart disease
- No evidence of myocardial infarction within the past 3 months
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Human antichimeric antibody (HACA) titer no greater than 48 ng/mL
- No anatomical or physiological considerations that would preclude study participation
- No active autoimmune disease, active infection, or traumatic injury requiring treatment
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 8 weeks since prior external beam or gamma knife radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior investigational treatment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28207-1830
Temple University
Philadelphia, Pennsylvania, 19140
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.
Read the detailed description
OBJECTIVES:
- Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.
- Determine the median survival time of these patients treated with this regimen.
- Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic, hematologic, and biochemical profiles in these patients.
- Confirm the maximum tolerated dose of this regimen in these patients.
- Optimize the drug delivery of this regimen in these patients.
- Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed. One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial response, minimal response, or stable disease repeat the above treatments during week 9. Patients with complete response, progressive disease, or unacceptable toxicity receive no additional treatment.
Patients are followed every month until disease progression. All patients regardless of disease progression or retreatment are followed at 36 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with recurrent anaplastic astrocytoma) will be accrued for this study.
- Conditions
- Brain and Central Nervous System Tumors
- Being tested
- conventional surgery, iodine I 131 monoclonal antibody TNT-1/B
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
iodine I 131 monoclonal antibody TNT-1/BRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2000
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
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peregrine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terrence G. Chew, MD, Study chair, Peregrine Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004017
- Sponsor's protocol ID
- CDR0000067235
- Other IDs
- PEREGRINE-TNT9802, MUSC-7993, PEREGRINE-BB-IND-7344, TCLONE-BB-IND-7344, TCLONE-TNT9802, NCI-G99-1560
- Status last verified
- Mar 2003
- First submitted
- 1 Nov 1999
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
- ClinicalTrials.gov ID
- NCT00004017
- Acronym / sponsor ID
- CDR0000067235
- Conditions
- Brain and Central Nervous System Tumors
- Keywords
- recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peregrine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- First posted
- 27 Jan 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: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.
Detailed description
OBJECTIVES:
- Determine the median time to disease progression in patients with newly diagnosed unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.
- Determine the median survival time of these patients treated with this regimen.
- Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic, hematologic, and biochemical profiles in these patients.
- Confirm the maximum tolerated dose of this regimen in these patients.
- Optimize the drug delivery of this regimen in these patients.
- Assess the response of these patients in terms of MRI measured gadolinium enhanced tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last dose of study drug.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed. One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial response, minimal response, or stable disease repeat the above treatments during week 9. Patients with complete response, progressive disease, or unacceptable toxicity receive no additional treatment.
Patients are followed every month until disease progression. All patients regardless of disease progression or retreatment are followed at 36 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with recurrent anaplastic astrocytoma) 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 |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
| iodine I 131 monoclonal antibody TNT-1/B | Radiation | – |
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 9 Feb 2009.
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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.
Terrence G. Chew, MD study chair
Peregrine Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional surgery and iodine I 131 monoclonal antibody TNT-1/B in people with Brain and Central Nervous System Tumors, run by Peregrine Pharmaceuticals at 4 sites 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 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 9 Feb 2009.