NeuroblastomaPhase 2NCT00002560
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
A Phase 2 study testing monoclonal antibody 3F8 and sargramostim in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer Center 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. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- monoclonal antibody 3F8 and sargramostim
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1994to Apr 2005
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Neuroblastoma diagnosed by INSS criteria, i.e., either:
- Histologic proof of disease OR
- Tumor clumps in bone marrow plus elevated catecholamine levels
- Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
- N-myc amplification in tumor cells
- Diploid chromosomal content in tumor cells
- Distant skeletal metastases
- Unresectable primary tumor crossing the midline
- Bone marrow with greater than 10% tumor cells
- Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
- No rapidly progressive disease
- Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols
PATIENT CHARACTERISTICS:
Age:
- 2 to 21
Performance status:
- Not specified
Life expectancy:
- Greater than 8 weeks
Hematologic:
- Not specified
Hepatic:
- No grade 3/4 toxicity
- LDH no greater than 1.5 times upper limit of normal
Renal:
- Creatinine clearance at least 60 mL/min
- No grade 3/4 toxicity
Cardiovascular:
- No grade 3/4 toxicity
Pulmonary:
- No grade 3/4 toxicity
Other:
- No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
- No active life threatening infections
- No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
- No allergy to mouse proteins
- No pain requiring opiates
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
Read the detailed description
OBJECTIVES:
- Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
- Assess the biological effects of 3F8/GM-CSF in these patients.
OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
- Conditions
- Neuroblastoma
- Being tested
- monoclonal antibody 3F8, sargramostim
- Keywords
- recurrent neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monoclonal antibody 3F8Biological
sargramostimBiological
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 1994
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer 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 2
- Primary purpose
- Treatment
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Brian H. Kushner, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002560
- Sponsor's protocol ID
- 94-018
- Other IDs
- CDR0000063466, NCI-V94-0416
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 28 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
- ClinicalTrials.gov ID
- NCT00002560
- Acronym / sponsor ID
- 94-018
- Conditions
- Neuroblastoma
- Keywords
- recurrent neuroblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 1994
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- 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: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
Detailed description
OBJECTIVES:
- Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
- Assess the biological effects of 3F8/GM-CSF in these patients.
OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 3F8 | Biological | – |
| sargramostim | 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 28 Jun 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.
Brian H. Kushner, MD study chair
Memorial Sloan Kettering Cancer Center
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 monoclonal antibody 3F8 and sargramostim in people with Neuroblastoma, run by Memorial Sloan Kettering Cancer 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 28 Jun 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.
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 28 Jun 2013.