Status:
COMPLETED
Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neoplasms
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 1994
Trial Type :
INTERVENTIONAL
End Date :
July 1 2000
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00001387
Start Date
September 1 1994
End Date
July 1 2000
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892