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Bortezomib in Treating Children With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00021216
First received: July 11, 2001
Last updated: December 6, 2013
Last verified: December 2013
History of Changes
  Purpose

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. 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
Other: laboratory biomarker analysis
Other: pharmacological study
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Of PS-341 In Pediatric Patients With Refractory Solid Tumors

Resource links provided by NLM:

Drug Information available for: Bortezomib
U.S. FDA Resources

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

Primary Outcome Measures:
  • MTD defined as the dose at which fewer than 20% of patients experience DLT assessed using CTC version 2.0 [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  • 20S proteasome inhibition [ Time Frame: Up to 2 weeks ] [ Designated as safety issue: No ]
    The 95% confidence interval for the percent of patients who exhibit inhibition at a recommended dose level determined according to the table above is 61%-100%, if six patients are evaluated or 55%-100% if five patients are evaluated.

  • Progression free survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 36
Study Start Date: November 2001
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bortezomib)
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.
 Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Blaney Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00021216     History of Changes
Other Study ID Numbers: NCI-2012-01860, NCI-2012-01860, COG-ADVL0015, CDR0000068760, ADVL0015, ADVL0015, U01CA097452
Study First Received: July 11, 2001
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015