Bortezomib in Treating Children With Advanced Solid Tumors

NCT ID: NCT00021216

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2005-12-31

Brief Summary

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.

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

pharmacological study

Intervention Type: OTHER

Correlative studies

Interventions

bortezomib

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

pharmacological study

Correlative studies

Intervention Type: OTHER

Other Intervention Names

LDP 341; MLN341; VELCADE; pharmacological studies

Eligibility 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Blaney

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Oncology Group

Arcadia, California, United States

Countries

United States

Other Identifiers

NCI-2012-01860

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-ADVL0015

Identifier Type: -

Identifier Source: secondary_id

CDR0000068760

Identifier Type: -

Identifier Source: secondary_id

ADVL0015

Identifier Type: OTHER

Identifier Source: secondary_id

ADVL0015

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA097452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01860

Identifier Type: -

Identifier Source: org_study_id