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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021216 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of bortezomib in treating children who have advanced solid tumors that have not responded to previous treatment.
Condition | Intervention | Phase |
---|---|---|
Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: bortezomib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. If dose-limiting toxicity in the form of myelosuppression occurs in stratum I, dose escalation continues with patients meeting the qualifications for stratum II.
PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
Stratum II only:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Stratum II only:
Chemotherapy:
Stratum II only:
Endocrine therapy:
Radiotherapy:
Stratum II only:
Surgery:
Other:
Study Chair: | Susan M. Blaney, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000068760, COG-ADVL0015 |
Study First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00021216 History of Changes |
Health Authority: | United States: Federal Government |
unspecified childhood solid tumor, protocol specific |
Bortezomib Protease Inhibitors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Bortezomib |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |