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beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma Clinical research trials and beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma. beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma clinical trial. Test subjects typically receive the most expert healthcare available for their beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma  beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
For Condition: recurrent neuroblastoma,disseminated neuroblastoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as beta-glucan use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining beta-glucan and monoclonal antibody may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining beta-glucan and monoclonal antibody in treating patients who have metastaticneuroblastoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of beta-glucan and monoclonal antibody 3F8 in patients with metastatic neuroblastoma. - Determine the toxicity of this regimen in these patients. - Assess the biological effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral beta-glucan and monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours on days 1-5 and 8-12. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of beta-glucan and MOAB 3F8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 6 months, every 2 months for 6 months, and then every 3-6 months for 2 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /49 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-risk stage 4 metastatic neuroblastoma - May be confirmed by bone marrow involvement and elevated urinary catecholamines - Progressive or persistent disease after intensive conventional chemotherapy that included induction with N6, N7, N8, or COG protocol with or without bone marrow or stem cell transplantation - Poor long-term prognosis as defined by any of the following: - N-myc amplification in tumor cells - Diploid chromosomal content plus 1p loss of heterozygosity in tumor cells - Distant skeletal metastases - Unresectable primary tumor infiltrating across the midline - More than 10% tumor cells in bone marrow - Measurable or evaluable disease documented at least 4 weeks after completion of prior systemic therapy PATIENT CHARACTERISTICS: Age: - Under 50 Performance status: - Not specified Life expectancy: - See Disease Characteristics Hematopoietic: - Platelet count greater than 25,000/mm^3 - Absolute neutrophil count greater than 500/mm^3 Hepatic: - Not specified Renal: - Creatinine clearance greater than 60 mL/min Other: - No severe major organ toxicity - No active life-threatening infections - No prior allergy to mouse proteins - No prior allergy to beta-glucan, oats, barley, mushrooms, or yeast - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No other concurrent supplemental beta-glucan either as food (e.g., bran cereals) or as complementary medicine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Nai-KongCheung, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Nai-Kong Cheung 212-639-8401
Additional Information:
Study ID Numbers: CDR0000069348; MSKCC-01075,NCI-G02-2067
Study Start Date:
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037011
Other Disseminated Neuroblastoma Studies:
1. Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma
2. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
3. Combination Chemotherapy in Treating Children With Neuroblastoma
4. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
5. Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
Related Studies:
Other disseminated neuroblastoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
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