|
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma Clinical research trials and Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma. Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma  Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
For Condition: recurrent neuroblastoma,disseminated neuroblastoma,regional neuroblastoma,localized unresectable neuroblastoma,stage 4S neuroblastoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.
Details: OBJECTIVES: - Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma. - Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen. - Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients. OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes [primary refractory bone marrow disease] vs no [no evidence of disease]). Patients receive sargramostim (GM-CSF) subcutaneously (or IV over 2 hours during course 4 only) on days -5 to 11 and monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients with evaluable disease (primary refractory bone marrow disease) are removed from study after course 3 if there is no evidence of response. Beginning after 2 courses (or after 1 course if human anti-mouse antibody develops and precludes timely administration of course 2) of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14. Isotretinoin repeats approximately every 28 days for 6 courses. PROJECTED ACCRUAL: A total of 15-90 patients (15-45 patients with evaluable disease [primary refractory bone marrow disease] and 45 patients with no evaluable disease [no evidence of disease]) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of high-risk neuroblastoma by histology OR bone marrow metastases and high urine catecholamine levels, including any of the following International Neuroblastoma Staging System stages: - Stage 4 with (any age) OR without (over 1 year of age) MYCN amplification - MYCN-amplified stage 3 (unresectable, any age) - MYCN-amplified stage 4S - Evaluable disease that is resistant to standard therapy (incomplete response in bone marrow) with no MIBG-avid soft tissue tumor and no progressive disease OR no evaluable or measurable disease (i.e., patient is in complete/very good partial remission) PATIENT CHARACTERISTICS: Age - Any age Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - No concurrent grade 3 or greater hepatic toxicity Renal - No concurrent grade 3 or greater renal toxicity Cardiac - No concurrent grade 3 or greater cardiac toxicity Pulmonary - No concurrent grade 3 or greater pulmonary toxicity Other - Not pregnant - Negative pregnancy test - No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL - No concurrent grade 3 or greater neurologic toxicity - No concurrent grade 3 or greater gastrointestinal toxicity - No history of allergy to mouse proteins - No active life-threatening infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianKushner, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Brian Kushner 212-639-6793
Additional Information:
Study ID Numbers: CDR0000339611; MSKCC-03077
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072358
Other Localized Unresectable Neuroblastoma Studies:
1. Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma
2. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
3. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
4. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
5. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
Related Studies:
Other localized unresectable neuroblastoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
|
|
|
|
|
|
|
|
