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A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors 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 A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors Clinical research trials and A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors 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 A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors. A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors 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 A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors 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 > "A" Clinical Trials Conditions > A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors  A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
For Condition: Brain Neoplasms,Glioma,Medulloblastoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
Details: The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site. RMP-7 is a synthetic bradykinin analog which specifically binds to B2 receptors expressed on the brain capillary endothelial cells and preferentially increases capillary permeability within CNS tumors. Carboplatin is an anticancer agent with preclinical and clinical antitumor activity against a variety of brain tumors. A pediatric phase I trial of the combination of RMP-7 and carboplatin will be conducted to determine the maximum tolerated dose of RMP-7 in children with refractory brain tumors.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically confirmed brain tumor including but not limited to the following: Anaplastic astrocytoma, Glioblastoma multiforme, Low-grade glioma, Ependymoma, Medulloblastoma, Pineal tumors, Chiasmal glioma, Craniopharyngioma, Brain stem glioma (requirement for histologic diagnosis may be waived). Disease refractory to standard therapy or no standard chemotherapy exists and ineligible for potential curative surgery or radiotherapy. Measurable or evaluable disease on radiographic studies with evidence of progression on prior chemotherapy or radiotherapy or persistent disease after surgery. PRIOR/CURRENT THERAPY: See Disease Characteristics At least 6 months since carboplatin. At least 3 weeks since myelosuppressive therapy. Patients who received stem cell or bone marrow rescue after nitrosourea therapy are eligible after 3 weeks if they have recovered from hematologic toxicities of their prior therapy. Concurrent steroids allowed if dose stable for at least 2 weeks prior to entry. Recovered from toxic effects of any prior therapy. PATIENT CHARACTERISTICS: Age: 21 and under. Performance status: ECOG 0-2. Life expectancy: At least 8 weeks. HEMATOLOGIC: Absolute granulocyte count greater than 1,500/mm(3). Platelet count greater than 100,000/mm(3) (at least 75,000/mm(3) in patients with prior bone marrow transplantation or craniospinal irradiation). Hemoglobin greater than 8.0 g/dL. HEPATIC: Bilirubin no greater than 2 times normal. ALT no greater than 2 times normal. RENAL: Creatinine within normal limits for age as follows: Age (in years) -- Creatinine (in mg/dL): Younger than 5 -- no greater than 1.2; 5-10 -- no greater than 1.5; 10-15 -- no greater than 1.8; Older than 15 -- no greater than 2.4. OTHER: No significant systemic illness. No pregnant or nursing women. Negative pregnancy test required of fertile women. Effective contraception required of fertile patients. Durable power of attorney required of all patients 18-21 years of age.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960068; 96-C-0068
Study Start Date: April 24, 1996
Record last reviewed: February 10, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001502
Other Medulloblastoma Studies:
1. A Phase I Trial of CC-8490 for the Treatment of Patients with Recurrent/Refractory High-Grade Gliomas
2. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
3. Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
4. Safety and tolerability study of 131I-TM-601 to treat adult patients with recurrent glioma.
5. OSI-774 to Treat Patients with Recurrent Malignant Glioma (Brain Tumor) and Patients with Glioma After Radiation Therapy
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Other Medulloblastoma Clinical Trials
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A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
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