Sunitinib in Treating Young Patients With Refractory Solid Tumors

NCT00387920 | Completed Phase 1

• 6 other identifiers: NCI-2009-00361CDR0000507414COG-ADVL0612NCI-07-C-0220ADVL0612U01CA097452
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 17

Brief Summary

This phase I trial is studying the side effects and best dose of sunitinib in treating young patients with refractory solid tumors. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor.

Conditions

Central Nervous System Metastases; Childhood Central Nervous System Choriocarcinoma; Childhood Central Nervous System Embryonal Tumor; Childhood Central Nervous System Germ Cell Tumor; Childhood Central Nervous System Germinoma; Childhood Central Nervous System Mixed Germ Cell Tumor; Childhood Central Nervous System Teratoma; Childhood Central Nervous System Yolk Sac Tumor; Recurrent Childhood Central Nervous System Embryonal Tumor; Unspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

• MTD and recommended phase II dose

  MTD will be the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT).

  During course 1 of therapy

• Adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  Weekly during course 1, assessed up to 35 days

• Pharmacokinetics of sunitinib malate using liquid spectrometry/mass spectroscopy methods

  At baseline and days 1, 7, 14, 21, and 28 of course 1

• Tolerability and pharmacokinetic profile of capsule contents sprinkled over applesauce or yogurt

  At baseline and days 1, 7, 14, 21, and 28 of course 1

Secondary Outcomes (1)

• Correlative studies

  Days 1 and 28 of course 1

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

PART A: Patients receive oral sunitinib malate once daily on days 1-28 days. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. PART B: Patients receive sunitinib malate capsule contents sprinkled over applesauce or yogurt once daily on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After the first course, patients may switch to capsule formulation for convenience.

Drug: sunitinib malate; Other: pharmacological study; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Other: laboratory biomarker analysis

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Treatment (enzyme inhibitor therapy)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (enzyme inhibitor therapy)

dynamic contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo DCE-MRI

Also known as: DCE-MRI

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed solid tumor (not required for patients with intrinsic brain stem tumors or optic pathway gliomas)
• Recurrent or refractory disease
• Measurable or evaluable disease
• No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
• Patients with metastatic bone marrow disease are eligible but are not evaluable for hematologic toxicity
• Must not be refractory to red blood cell or platelet transfusions
• Primary CNS tumors or known CNS metastases allowed
• Neurological deficits must have been relatively stable for ≥ 1 week before study enrollment
• No imaging evidence of prior intracranial hemorrhage
• No evidence of new CNS hemorrhage on baseline MRI obtained within 14 days before study enrollment (ECHO gradient MRI sequences per institutional guidelines required for evaluation of CNS hemorrhage)
• The presence of small punctuate CNS hemorrhage on these scans will exclude a patient from participation
• No known bone marrow metastatic disease
• No tumors involving the pleural surface
• Karnofsky performance status (PS) 50-100% (\> 10 years of age) OR Lansky PS 50-100% (≤ 10 years of age)
• Absolute neutrophil count ≥ 1,000/mm³\*

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868-3874, United States

Location

UCSF-Mount Zion

San Francisco, California, 94115, United States

Location

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

• Wang E, DuBois SG, Wetmore C, Verschuur AC, Khosravan R. Population Pharmacokinetics of Sunitinib and its Active Metabolite SU012662 in Pediatric Patients with Gastrointestinal Stromal Tumors or Other Solid Tumors. Eur J Drug Metab Pharmacokinet. 2021 May;46(3):343-352. doi: 10.1007/s13318-021-00671-7. Epub 2021 Apr 14.

  PMID: 33852135 DERIVED

• Wang E, DuBois SG, Wetmore C, Khosravan R. Population pharmacokinetics-pharmacodynamics of sunitinib in pediatric patients with solid tumors. Cancer Chemother Pharmacol. 2020 Aug;86(2):181-192. doi: 10.1007/s00280-020-04106-z. Epub 2020 Jul 4.

  PMID: 32623479 DERIVED

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Steven DuBois

  COG Phase I Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2012
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

CA (2); US (15)