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Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy Clinical research trials and Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy. Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy clinical trial. Subjects often receive the most expert healthcare possible for their Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.

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Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy



Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients with Refractory Malignancy

For Condition: Neoplasms
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.
Details: Paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies. The optimal dose and schedule has not yet been determined in either adults or children. The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy. In addition, the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined.
Eligibility:
Study Type:
  Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically confirmed cancer (including leukemia) that is: Refractory to standard therapy (objective disease progression required) OR For which no standard therapy exists and patient is ineligible for potentially curative surgery. PRIOR/CONCURRENT THERAPY: Recovery from the toxic effects of prior therapy required. Biologic Therapy: Not specified. Chemotherapy: No prior taxanes. At least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea). Endocrine Therapy: Not specified. Radiotherapy: Prior extensive craniospinal or pelvic irradiation allowed. Surgery: Ineligible for potential curative surgery. Other: Prior bone marrow transplant allowed. PATIENT CHARACTERISTICS: Age: Over 1 to 21; Performance status: ECOG 0-2; Life expectancy: At least 8 weeks. Hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy). Absolute granulocyte count at least 1,500/mm(3); Platelet count at least 100,000/mm(3); Hemoglobin at least 8.0 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL OR; Creatinine clearance at least 60 mL/min per square meter. OTHER: No concurrent anticonvulsant therapy. No grade 2 or worse neuropathy. No significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity. Not pregnant or nursing.
Total Enrollment: 25

Location and Contact Information:

National Cancer Institute (NCI)
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:
  940204;  94-C-0204
Study Start Date: September 14, 1994
Record last reviewed: August 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001387

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