Full Text View
Tabular View
No Study Results Posted
Related Studies
Bortezomib in Treating Children With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00021216   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
November 2001
 
 
 
Complete list of historical versions of study NCT00021216 on ClinicalTrials.gov Archive Site
 
 
 
Bortezomib in Treating Children With Advanced Solid Tumors
A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors

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.

OBJECTIVES:

  • Determine the maximum tolerated dose of bortezomib in pediatric patients with refractory solid tumors.
  • Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients.
  • 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.

Phase I
Interventional
Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: bortezomib
 
Blaney SM, Bernstein M, Neville K, Ginsberg J, Kitchen B, Horton T, Berg SL, Krailo M, Adamson PC. Phase I study of the proteasome inhibitor bortezomib in pediatric patients with refractory solid tumors: a Children's Oncology Group study (ADVL0015). J Clin Oncol. 2004 Dec 1;22(23):4804-9. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Karnofsky 50-100% (over 10 years of age)
  • Lansky 50-100% (10 years of age and under)

Life expectancy:

  • At least 8 weeks

Hematopoietic:

  • 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)

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • ALT less than 5 times normal for age
  • Albumin at least 2 g/dL

Renal:

  • Creatinine no greater than upper limit of normal for age OR
  • Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • 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

Endocrine therapy:

  • Concurrent dexamethasone allowed for CNS tumors if stable dose for at least 2 weeks

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • No prior bortezomib
  • No concurrent anticonvulsants
  • No other concurrent investigational agents
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00021216
 
CDR0000068760, COG-ADVL0015
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Susan M. Blaney, MD Texas Children's Cancer Center
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP