Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| COG-99703 | Other Identifier | Children's Oncology Group | |
| CCG-99703 | Other Identifier | Children's Cancer Group | |
| CDR0000065924 | Other Identifier | Clinical Trials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (combination chemotherapy, PBSC transplant) | Experimental | Pts undergo conventional surgery for diagnosis & max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) & undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Maximal tolerated dose of thiotepa for consolidation therapy | The dose level will be assigned within 3 working days prior to beginning Consolidation. | 9 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
DISEASE CHARACTERISTICS:
Histologically proven malignant brain or spinal cord tumor, including the following:
Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce H. Cohen, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States | ||
| Childrens Hospital Los Angeles |
Not provided
Not provided
Not provided
Not provided
Not provided
| carboplatin | Drug | Given IV |
|
|
| cisplatin | Drug | Given IV |
|
|
| cyclophosphamide | Drug | Given IV |
|
|
| etoposide | Drug | Given IV |
|
|
| thiotepa | Drug | Given IV |
|
|
| vincristine sulfate | Drug | Given IV |
|
|
| conventional surgery | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| Los Angeles |
| California |
| 90027 |
| United States |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | 90048-1865 | United States |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California | 90095-1781 | United States |
| Children's Hospital Central California | Madera | California | 93638-8762 | United States |
| Children's Hospital and Research Center Oakland | Oakland | California | 94609 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Kaiser Permanente Medical Center - Oakland | Sacramento | California | 95825 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado | 80045 | United States |
| Presbyterian - St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut | 06360-2875 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010-2970 | United States |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia | 30322 | United States |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia | 30912-3730 | United States |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202-5289 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Kosair Children's Hospital | Louisville | Kentucky | 40232 | United States |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan | 48109-0286 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503-2560 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-5381 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Children's Hospitals and Clinics of Minnesota - St. Paul | Saint Paul | Minnesota | 55102-2392 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89109-2306 | United States |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Overlook Hospital | Morristown | New Jersey | 07962 | United States |
| St. Joseph's Hospital and Medical Center | Paterson | New Jersey | 07503 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Beth Israel Medical Center - Petrie Division | New York | New York | 10003-3803 | United States |
| NYU Cancer Institute at New York University Medical Center | New York | New York | 10016 | United States |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308-1062 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106-5000 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205-2696 | United States |
| Dayton Children's - Dayton | Dayton | Ohio | 45404-1815 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104-9786 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas | 79106 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229-3993 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507-1971 | United States |
| Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington | 98105 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Deaconess Medical Center | Spokane | Washington | 99210-0248 | United States |
| Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington | 98405 | United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6001 | Australia |
| Children's & Women's Hospital of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | S4T 7T1 | Canada |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009447 | Neuroblastoma |
| D012509 | Sarcoma |
| D001254 | Astrocytoma |
| D016545 | Choroid Plexus Neoplasms |
| D013120 | Spinal Cord Neoplasms |
| D018335 | Rhabdoid Tumor |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D005910 | Glioma |
| D002551 | Cerebral Ventricle Neoplasms |
| D013118 | Spinal Cord Diseases |
| D018193 | Neoplasms, Complex and Mixed |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D013852 | Thiotepa |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided