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Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine


Phase 1
3 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Vincristine, Etoposide and Cyclosporine A in Concert With Standard Dose Radiation Therapy in Diffuse Intrinsic Brain Stem Glioma - A Phase I Study of Dose Escalation of Vincristine


OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
vincristine given as an IV push dose in combination with continuous infusion cyclosporine
and oral etoposide concurrent with and prior to radiotherapy in children with newly
diagnosed primary intrinsic brain stem glioma. II. Determine the incidence and severity of
other toxicities of vincristine in this regimen in these patients. III. Determine a safe and
tolerable dose of vincristine under these conditions to be used in phase II studies. IV.
Seek preliminary evidence of antitumor activity in this setting in these patients.

OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily
for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of
vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and
cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion.
Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity
(DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been
exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6
monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on
day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4
years and then annually thereafter.

PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12
patients per year.

Inclusion Criteria


DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI Biopsy
is neither necessary nor encouraged A least two-thirds of the tumor is in the pons Origin
of the tumor is clearly in the pons Must be registered within 28 days of diagnosis
Clinical history less than 6 months duration (cranial nerve deficit, long tract signs, or
ataxia) No diffuse leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life
expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3
Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal:
Creatinine normal for age OR Creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at
stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not
specified Other: No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mark L. Greenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Hospital for Sick Children

Authority:

United States: Federal Government

Study ID:

CDR0000066706

NCT ID:

NCT00003625

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood brain stem glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Texas Medical BranchGalveston, Texas  77555-1329
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Nemours Children's ClinicJacksonville, Florida  32207
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Floating Hospital for ChildrenBoston, Massachusetts  02111
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Via Christi Regional Medical Center-Saint Francis CampusWichita, Kansas  67214
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
Christ HospitalOak Lawn, Illinois  60453
Carilion Roanoke Memorial HospitalRoanoke, Virginia  24029
West Virginia University Medical School, Charleston DivisionCharleston, West Virginia  25304