Brain and Central Nervous System TumorsPhase 1NCT00002754
Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors
A Phase 1 study testing monoclonal antibody Me1-14 F(ab')2 in people with Brain and Central Nervous System Tumors and Melanoma (Skin), run by Duke University at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer
- What is being tested?
- monoclonal antibody Me1-14 F(ab')2
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1993to Apr 2001
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed primary or metastatic malignant melanoma OR Histologically confirmed supratentorial malignant brain tumor Newly diagnosed or recurrent primary or metastatic tumor Eligible primary histologies, including but not limited to: Glioblastoma multiforme Mixed anaplastic glioma Anaplastic astrocytoma Other astrocytoma Gliosarcoma Anaplastic oligodendroglioma The following excluded: Diffusely infiltrating tumors Multifocal tumors Infratentorial tumors Subependymal spread No measurable enhancing lesion extending more than 1 cm beyond margins of surgical cavity on contrast-enhanced CT or MRI performed within 72 hours after resection Intralesional catheter placed at resection Patency of catheter demonstrated by radiolabeled albumin flow Reactivity of neoplastic cells with intact Me1-14 IgG2a or Me1-14 F(ab')2 demonstrated by immunohistology with polyclonal rabbit antibody or monoclonal mouse antibody
PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50%-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic chemotherapy unless unequivocal tumor progression Endocrine therapy: Concurrent corticosteroids allowed at lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least 3 months since radiotherapy to site of measurable disease within the nervous system unless unequivocal tumor progression Surgery: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
Official title: PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors.
Read the detailed description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of iodine-131-labeled monoclonal antibody fragment ME1-14 F(ab')2 administered intracystically in patients with recurrent or newly diagnosed primary or metastatic malignant melanoma or other brain tumors. II. Identify any objective therapeutic responses to this treatment.
OUTLINE: All patients receive a fixed dose of monoclonal antibody fragment ME1-14 F(ab')2 via an intralesional catheter; cohorts of 3-6 patients receive escalating doses of isotope conjugated to the antibody until the maximum tolerated dose is determined. Patients with newly diagnosed disease at entry may receive additional therapy with external-beam radiotherapy beginning 4 months after radioimmunotherapy (or sooner if disease progression occurs). Patients with recurrent disease at entry are followed without further therapy for at least 4 months after radioimmunotherapy; alternative therapy may be offered upon progression. All patients are followed at 4, 8, 16, and 24 weeks after treatment, then every 12 weeks for 1 year.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
- Being tested
- monoclonal antibody Me1-14 F(ab')2
- Keywords
- recurrent adult brain tumor, adult glioblastoma, stage IV melanoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma, recurrent childhood cerebral astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Melanoma, Neoplasm Metastasis, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal antibody Me1-14 F(ab')2Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2004 (estimated)
- Study startFeb 1993
- Primary completionApr 2001
- Study completionApr 2001
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 Duke UniversityThe 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
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Darell D. Bigner, MD, PhD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002754
- Sponsor's protocol ID
- CDR0000064690
- Other IDs
- DUMC-0334-99-2R6, DUMC-219-96-2R3, DUMC-302-97-2R4, DUMC-308-98-2R5, NCI-V96-1071
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 20 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS
- ClinicalTrials.gov ID
- NCT00002754
- Acronym / sponsor ID
- CDR0000064690
- Keywords
- recurrent adult brain tumor, adult glioblastoma, stage IV melanoma, tumors metastatic to brain, childhood high-grade cerebral astrocytoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult mixed glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1993
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (actual)
- First posted
- 29 Jul 2004 (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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors.
Detailed description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of iodine-131-labeled monoclonal antibody fragment ME1-14 F(ab')2 administered intracystically in patients with recurrent or newly diagnosed primary or metastatic malignant melanoma or other brain tumors. II. Identify any objective therapeutic responses to this treatment.
OUTLINE: All patients receive a fixed dose of monoclonal antibody fragment ME1-14 F(ab')2 via an intralesional catheter; cohorts of 3-6 patients receive escalating doses of isotope conjugated to the antibody until the maximum tolerated dose is determined. Patients with newly diagnosed disease at entry may receive additional therapy with external-beam radiotherapy beginning 4 months after radioimmunotherapy (or sooner if disease progression occurs). Patients with recurrent disease at entry are followed without further therapy for at least 4 months after radioimmunotherapy; alternative therapy may be offered upon progression. All patients are followed at 4, 8, 16, and 24 weeks after treatment, then every 12 weeks for 1 year.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 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 |
|---|---|---|
| monoclonal antibody Me1-14 F(ab')2 | Biological | – |
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 20 Feb 2013.
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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.
Darell D. Bigner, MD, PhD study chair
Duke Cancer Institute
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 monoclonal antibody Me1-14 F(ab')2 in people with Brain and Central Nervous System Tumors and Melanoma (Skin), run by Duke University 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 20 Feb 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 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 20 Feb 2013.