Bortezomib in Treating Children With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00021216

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2001-11-01

Expected to finish

2005-12-01

Last updated by the study team

2015-04-15

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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