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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003141
Other study ID # 99703
Secondary ID COG-99703CCG-997
Status Completed
Phase Phase 1
First received November 1, 1999
Last updated March 27, 2014
Start date March 1998
Est. completion date October 2011

Study information

Verified date March 2014
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.


Description:

OBJECTIVES:

- Determine the maximum tolerated dose of thiotepa in infants with malignant brain or spinal cord tumors receiving intensive chemotherapy.

- Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood stem cell (PBSC) rescue in these patients.

- Assess the feasibility of harvesting PBSCs in these patients.

- Determine the complete response rate and overall event-free survival rate in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

Patients undergo surgery for diagnosis and maximal tumor resection.

Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.

Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date October 2011
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically proven malignant brain or spinal cord tumor, including the following:

- Primitive neuroectodermal tumor

- Ganglioneuroblastoma

- Medulloblastoma neuroblastoma

- Desmoplastic medulloblastoma

- Medulloepithelioma

- Ependymoma neuroepithelioma

- Anaplastic ependymoma germ cell tumor

- Astrocytoma germinoma

- Anaplastic astrocytoma

- Embryonal carcinoma

- Glioblastoma endodermal sinus tumor

- Gliosarcoma malignant teratoma

- Choroid plexus carcinoma

- Mixed germ cell tumor

- Cerebellar sarcoma

- Pineoblastoma

- Atypical teratoid/rhabdoid tumor

- Choriocarcinoma

- Teratoma (malignant or with malignant transformations)

- Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 6 months to less than 3 years

Performance Status:

- Not specified

Life Expectancy:

- More than 8 weeks

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

Renal:

- Glomerular filtration rate or creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior biologic therapy

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- No more than 6 weeks since prior surgery

- Recovered from prior surgery (stable)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
filgrastim
Given IV
Drug:
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
etoposide
Given IV
thiotepa
Given IV
vincristine sulfate
Given IV
Procedure:
conventional surgery

peripheral blood stem cell transplantation


Locations

Country Name City State
Australia Princess Margaret Hospital for Children Perth Western Australia
Canada Allan Blair Cancer Centre at Pasqua Hospital Regina Saskatchewan
Canada Hospital for Sick Children Toronto Ontario
Canada Children's & Women's Hospital of British Columbia Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
United States Akron Children's Hospital Akron Ohio
United States Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo Texas
United States C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor Michigan
United States AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Atlanta Georgia
United States MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia
United States Children's Hospital Center for Cancer and Blood Disorders Aurora Colorado
United States Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx New York
United States Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina
United States University of Chicago Cancer Research Center Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Rainbow Babies and Children's Hospital Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Dayton Children's - Dayton Dayton Ohio
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States City of Hope Comprehensive Cancer Center Duarte California
United States CCOP - MeritCare Hospital Fargo North Dakota
United States Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington Connecticut
United States Cook Children's Medical Center - Fort Worth Fort Worth Texas
United States Butterworth Hospital at Spectrum Health Grand Rapids Michigan
United States Penn State Children's Hospital Hershey Pennsylvania
United States Indiana University Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States CCOP - Kalamazoo Kalamazoo Michigan
United States Children's Mercy Hospital Kansas City Missouri
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States Lucille P. Markey Cancer Center at University of Kentucky Lexington Kentucky
United States Childrens Hospital Los Angeles Los Angeles California
United States Jonsson Comprehensive Cancer Center at UCLA Los Angeles California
United States Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Los Angeles California
United States Kosair Children's Hospital Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Children's Hospital Central California Madera California
United States Winthrop University Hospital Mineola New York
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota
United States Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown New Jersey
United States Overlook Hospital Morristown New Jersey
United States Beth Israel Medical Center - Petrie Division New York New York
United States Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States NYU Cancer Institute at New York University Medical Center New York New York
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Children's Hospital and Research Center Oakland Oakland California
United States Children's Hospital of Orange County Orange California
United States St. Joseph's Hospital and Medical Center Paterson New Jersey
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Knight Cancer Institute at Oregon Health and Science University Portland Oregon
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Kaiser Permanente Medical Center - Oakland Sacramento California
United States Primary Children's Medical Center Salt Lake City Utah
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Children's Hospital and Regional Medical Center - Seattle Seattle Washington
United States Group Health Central Hospital Seattle Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States Deaconess Medical Center Spokane Washington
United States Children's Hospitals and Clinics of Minnesota - St. Paul St. Paul Minnesota
United States Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma Washington
United States Medical University of Ohio Cancer Center Toledo Ohio
United States Children's National Medical Center Washington District of Columbia
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Alfred I. duPont Hospital for Children Wilmington Delaware

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates Up to 4 weeks after completion of study treatment Yes
Primary Maximal tolerated dose of thiotepa for consolidation therapy The dose level will be assigned within 3 working days prior to beginning Consolidation. 9 weeks Yes
Primary Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV) Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria. Up to 6 years Yes
Secondary Event Free Survival From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up No
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