NCT00015899

Brief Summary

RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2001

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

3.7 years

First QC Date

May 6, 2001

Last Update Submit

October 13, 2009

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood craniopharyngiomachildhood central nervous system germ cell tumorchildhood oligodendrogliomachildhood choroid plexus tumorchildhood grade I meningiomachildhood grade II meningiomachildhood grade III meningiomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood medulloblastomarecurrent childhood visual pathway and hypothalamic gliomarecurrent childhood ependymomachildhood atypical teratoid/rhabdoid tumorchildhood spinal cord neoplasm

Outcome Measures

Primary Outcomes (3)

  • Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers

  • Maximum tolerated dose of SCH 66336

    Four weeks

  • Pharmacokinetics of SCH 66336

Secondary Outcomes (1)

  • Tumor response to SCH 66336

Interventions

lonafarnibDRUG
Also known as: SCH 66336

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or progressive (refractory) brain tumors * Histologic confirmation waived for brainstem gliomas * Bone marrow involvement allowed if transfusion independent PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * Lansky 60-100% OR * Karnofsky 60-100% Life expectancy: * More than 8 weeks Hematopoietic: * See Disease Characteristics * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL Hepatic: * Bilirubin no greater than upper limit of normal * SGPT and SGOT less than 2.5 times normal * Albumin greater than 3 g/dL * PT/PTT no greater than 120% upper limit of normal * No overt hepatic disease Renal: * Creatinine no greater than 1.5 times normal OR * Glomerular filtration rate greater than 70 mL/min * No overt renal disease Cardiovascular: * No overt cardiac disease Pulmonary: * No overt pulmonary disease Other: * Neurologic deficits allowed if stable for at least 1 week prior to study * More than 3rd percentile weight for height * Able to swallow pills * No uncontrolled infection * No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for up to 10 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 6 months since prior bone marrow transplantation * More than 1 week since prior growth factors Chemotherapy: * At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: * Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study * Concurrent oral contraceptives or other hormonal contraceptive methods allowed Radiotherapy: * More than 6 weeks since prior substantial bone marrow radiotherapy * More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation * More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites Surgery: * Not specified Other: * No concurrent enzyme-inducing anticonvulsant drugs * No other concurrent anticancer or experimental drug therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0372, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Kieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE. Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2007 Jul 20;25(21):3137-43. doi: 10.1200/JCO.2006.09.4243.

    PMID: 17634493RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsOligodendrogliomaChoroid Plexus NeoplasmsAstrocytomaMedulloblastomaOptic Nerve GliomaFamilial ependymomaRhabdoid TumorSpinal Cord Neoplasms

Interventions

lonafarnib

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCerebral Ventricle NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesNeoplasms, Complex and MixedSpinal Cord Diseases

Study Officials

  • Mark W. Kieran, MD, PhD

    Dana-Farber Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

January 1, 2002

Primary Completion

September 1, 2005

Study Completion

March 1, 2007

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

US(9)