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Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy Clinical research trials and Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy. Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy clinical trial. Participants typically obtain the most effective healthcare available for their Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy  Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy
Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy
For Condition: Brain Neoplasms,Neuroblastoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous catheter for each 28 day cycle. The first several days of drug administration should be inpatient. Cycles may be repeated if there is no tumor progression or dose limiting toxicities (DLT). There are no breaks between cycles. Once a minimum of 3 patients have completed at least 4 weeks of therapy without DLT, new patients will be entered at the next dose level.
Details: Phenylbutyrate is an aromatic fatty acid that is converted to phenylacetate in vivo by mitochondrial beta-oxidation to phenylacetate. Preclinical studies have shown that continuous exposure to phenylacetate or phenylbutyrate can induce tumor cytostasis and differentiation in a wide variety of cell lines including malignant gliomas and neuroblastomas. However, phenylbutyrate has been shown to be a more potent differentiating agent than phenylacetate in a variety of tumor cell lines. In addition, phenylbutyrate appears to have molecular activities that are distinct from phenylacetate. The objective of this trial is to determine the maximum tolerated dose and the toxicities of phenylbutyrate administered as a continuous intravenous infusion for 28 days. In addition, the pharmacokinetics of phenylbutyrate and its metabolite, phenylacetate, will be studied using both model-dependent and model-independent parameters.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Disease Characteristics: Histologically proven cancer that is refractory to standard therapy. Patients with neurofibromatosis having progressive inoperable plexiform neurofibromas with potential to cause significant morbidity are eligible. Patients with brainstem gliomas histology may have histology requirements waived. Patients without prior therapy are eligible if they have diseases with no available standard therapy. Patients with evidence of bone marrow involvement by tumor, or a history of either bone marrow transplantation or extensive radiotherapy will be eligible, but inevaluable for hematologic toxicities. Patients with greater than grade 2 neurocortical toxicity will be excluded. PRIOR/CONCURRENT THERAPY: Biologic Therapy: No concurrent hematopoietic growth factor. Chemotherapy: No chemotherapy within 3 weeks of study. No nitrosoursea within 6 weeks of study. No concurrent chemotherapy allowed. Must be on stable or decreasing dose of dexamethasone within 2 weeks of study. Endocrine Therapy: Not specified. Radiotherapy: No radiotherapy within 6 weeks of study. Surgery: Not specified. Other: Patient must be recovered from toxic effects of all prior therapy. Concurrent antibiotic therapy when appropriate. Patient Characteristics: Age: 2 to 21. Performance Status: ECOG 0-2. Life Expectancy: At least 8 weeks. Hematopoietic (hematologic requirements below do not apply to patients with histologically confirmed bone marrow involvement or history of either bone marrow transplantation or extensive radiotherapy; these patients are inevaluable for hematologic toxicity): Absolute granulocyte count (AGC) at least 1500/mm3. Platelet count at least 100,000/mm3. Hemoglobin at least 8 g/dL. Hepatic: Bilirubin no greater than 2 mg/Dl. SGPT less than 2 times normal. Renal: Creatinine no greater than 1.5 mg/Dl OR Creatinine clearance at least 60 Ml/min/square meter. Other: No systemic illness. Not pregnant or nursing. No amino acidurias or organic acidemias.
Total Enrollment: 35
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970051; 97-C-0051
Study Start Date: December 19, 1996
Record last reviewed: November 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001565
Other Neuroblastoma Studies:
1. New Therapeutic Strategies for Patients with Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma
2. Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer
3. Irinotecan in Treating Children With Refractory Solid Tumors
4. Study of the Emotional Needs of Caregivers of Stem Cell Transplantation Patients
5. Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
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Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients with Refractory Malignancy
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