Search / Trial NCT00001387

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Paclitaxel Pediatric Pharmacokinetics Phase I Toxicity

Description

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001387_2024-07-14.pdf

4.5 MB

NCT00001387_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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