A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
N/A
21 Years
Both
Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory
solid tumors.
II. Determine the dose-limiting toxicity and other toxic effects of this regimen in these
patients.
III. Preliminarily determine the antitumor activity of this regimen in these patients.
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.
Inclusion Criteria:
- Histologically confirmed solid tumor that is refractory to standard therapy or for
which no standard therapy exists
- Histologic confirmation not required for brainstem glioma or optic pathway tumor
- Ineligible for therapies of higher priority
- Stratum II only:
- No bone marrow involvement
- Performance status - Karnofsky 50-100% (over 10 years of age)
- Performance status - Lansky 50-100% (10 years of age and under)
- At least 8 weeks
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Hemoglobin at least 8 g/dL (RBC transfusions allowed)
- Bilirubin less than 1.5 mg/dL
- ALT less than 5 times normal for age
- Albumin at least 2 g/dL
- Creatinine no greater than upper limit of normal for age
- Creatinine clearance or radioisotope glomerular filtration rate greater than 70
mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Neurologic deficits related to CNS tumors allowed if relatively stable for at least
2 weeks
- No uncontrolled infection
- At least 7 days since prior biologic therapy and recovered
- At least 3 months since prior allogeneic stem cell transplantation
- At least 1 week since prior growth factors
- Stratum II only:
- No prior stem cell transplantation with or without total body irradiation
- At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
- Stratum II only:
- No more than 2 prior multi-agent chemotherapy regimens
- More than 2 single-agent regimens allowed
- Concurrent dexamethasone allowed for CNS tumors if stable dose for at least 2 weeks
- See Biologic therapy
- At least 2 weeks since prior palliative local radiotherapy
- At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least
50% of pelvis
- At least 6 weeks since prior substantial bone marrow radiotherapy
- Recovered from prior radiotherapy
- Stratum II only:
- No prior radiotherapy to more than 20% of bone marrow
- No prior bortezomib
- No concurrent anticonvulsants
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0
Outcome Time Frame:
3 weeks
Safety Issue:
Yes
Principal Investigator
Susan Blaney
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01860
NCT ID:
NCT00021216
Start Date:
November 2001
Completion Date:
Related Keywords:
- Unspecified Childhood Solid Tumor, Protocol Specific
- Neoplasms
Name | Location |
|---|---|
| Children's Oncology Group | Arcadia, California 91006-3776 |
