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.
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021216
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021216

  Show 59 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Susan M. Blaney, MD Texas Children's Cancer Center
  More Information

Additional Information:
Publications:
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

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:
Bortezomib
Protease Inhibitors

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009