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

• Status: Completed
• Trial end date: 2000-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.