A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
Phase 2
N/A
21 Years
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Both
Brain and Central Nervous System Tumors, Lymphoma, Neuroblastoma, Retinoblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors
OBJECTIVES:
I. Determine the response in children with solid tumors or non-Hodgkin's lymphoma treated
with rebeccamycin analogue.
II. Determine and maintain a plasma concentration of at least 5 µg/mL of this drug in these
patients.
III. Determine the toxicity of this drug in these patients. IV. Determine the
pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients with solid tumors are stratified according to tumor histology (neuroblastoma vs
Ewing's sarcoma [closed to accrual as of 5/19/03]/peripheral primative neuroectodermal tumor
[PNET] vs osteosarcoma [closed to accrual as of 5/19/03] vs rhabdomyosarcoma vs
non-Hodgkin's lymphoma vs other solid tumors). Patients with CNS tumors are stratified
according to tumor histology (medulloblastoma/PNET vs ependymoma vs brainstem glioma vs
other CNS tumors).
Patients receive rebeccamycin analogue IV over 1 hour on day 1. Treatment continues every 21
days for a total of 16 courses in the absence of disease progression or unacceptable
toxicity.
Patients are followed monthly for 1 year, every 2 months for 2 years, every 6 months for 1
year, and then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors
- Neuroblastoma
- Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)(Ewing's
sarcoma closed to accrual as of 5/19/03)
- Osteosarcoma (closed to accrual as of 5/19/03)
- Rhabdomyosarcoma
- Other extracranial solid tumors
- CNS/brain tumors:
- Medulloblastoma/PNET
- Ependymoma
- Brainstem glioma
- Other CNS tumors
- Histological verification may be waived for brainstem glioma and classic optic
glioma, but biopsy recommended OR
- Histologically or cytologically proven non-Hodgkin's lymphoma
- Refractory to standard treatment and no curative therapy available
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 21 and under at time of original diagnosis
Performance status:
- Karnofsky 50-100% in patients over 10 years of age
- Lansky 50-100% in patients age 10 and under
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 75,000/mm^3
- Hemoglobin greater than 8.0 g/dL
Hepatic:
- Bilirubin normal for age
- SGPT less than 2.5 times upper limit of normal
- Amylase normal
- Lipase normal
Renal:
- Creatinine normal for age OR
- Glomerular filtration rate at least 60 mL/min
Other:
- No concurrent uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Recovered from prior immunotherapy
Chemotherapy:
- At least 6 weeks since prior nitrosourea and recovered
- Recovered from any other prior chemotherapy
- No more than two prior chemotherapy regimens
Endocrine therapy:
- CNS tumor patients receiving dexamethasone must be on stable or decreasing dose at
least 2 weeks prior to study entry
Radiotherapy:
- At least 6 weeks since prior extended radiotherapy and recovered
- No prior total body irradiation
Surgery:
- Prior radiosurgery allowed
Other:
- No concurrent use of the following foods or medications:
- Grapefruit juice
- Erythromycin
- Azithromycin
- Clarithromycin
- Rifampin and analogues
- Fluconazole
- Ketoconazole
- Itraconazole
- Cimetidine
- Cannabinoids (marijuana or dronabinol)
- Leukotriene inhibitors (e.g., zafirlukast and zileuton)
- No other concurrent anticancer or investigational agents
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Anne-Marie Langevin, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-01851
NCT ID:
NCT00006102
Start Date:
July 2000
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Lymphoma
- Neuroblastoma
- Retinoblastoma
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
- childhood infratentorial ependymoma
- recurrent childhood rhabdomyosarcoma
- childhood supratentorial ependymoma
- childhood craniopharyngioma
- disseminated neuroblastoma
- recurrent neuroblastoma
- intraocular retinoblastoma
- extraocular retinoblastoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- recurrent childhood lymphoblastic lymphoma
- childhood central nervous system germ cell tumor
- unspecified childhood solid tumor, protocol specific
- childhood high-grade cerebral astrocytoma
- childhood oligodendroglioma
- childhood choroid plexus tumor
- childhood grade I meningioma
- childhood grade II meningioma
- childhood grade III meningioma
- stage III childhood large cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent childhood brain stem glioma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood medulloblastoma
- recurrent childhood visual pathway and hypothalamic glioma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood ependymoma
- recurrent retinoblastoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Nervous System Neoplasms
- Neuroblastoma
- Retinoblastoma
- Central Nervous System Neoplasms
- Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| Children's Hospital of Michigan | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| St. Vincent Hospital and Health Care Center | Indianapolis, Indiana 46260 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Marshfield Clinic | Marshfield, Wisconsin 54449 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| New York Medical College | Valhalla, New York 10595 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | Green Bay, Wisconsin 54301 |
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| St. Barnabas Medical Center | Livingston, New Jersey 07039 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Medical College of Georgia Comprehensive Cancer Center | Augusta, Georgia 30912-4000 |
| Holden Comprehensive Cancer Center | Iowa City, Iowa 52242-1009 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Baystate Medical Center | Springfield, Massachusetts 01199 |
| Michigan State University | East Lansing, Michigan 48824 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's Hospital of Denver | Denver, Colorado 80218 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
| Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
| Children's Hospital of Columbus | Columbus, Ohio 43205-2696 |
| Doernbecher Children's Hospital | Portland, Oregon 97201-3098 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| University of South Alabama Medical Center | Mobile, Alabama 36604 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
| Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego | San Diego, California 92120 |
| Children's Hospital San Diego | San Diego, California 92123-4282 |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
| Joe DiMaggio Children's Hospital at Memorial | Hollywood, Florida 33021 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| Nemours Children's Clinic-Orlando | Orlando, Florida 32806 |
| Sacred Heart Children's Hospital | Pensacola, Florida 32504 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Tampa Children's Hospital | Tampa, Florida 33677-4227 |
| St. Mary's Hospital | West Palm Beach, Florida 33407 |
| Children's Healthcare of Atlanta - Scottish Rite | Atlanta, Georgia 30342 |
| Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
| Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
| Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| Marlene and Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201-1595 |
| Floating Hospital for Children | Boston, Massachusetts 02111 |
| University of Massachusetts Memorial Medical Center - University Campus | Worcester, Massachusetts 01655 |
| St. John Hospital and Medical Center | Detroit, Michigan 48236 |
| University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Schneider Children's Hospital | New Hyde Park, New York 11042 |
| James P. Wilmot Cancer Center | Rochester, New York 14642 |
| Mission St. Joseph's Health System | Asheville, North Carolina 28801 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
| St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
| Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
| East Tennessee State University Cancer Center at JCMC | Johnson City, Tennessee 37604 |
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| Scott and White Memorial Hospital | Temple, Texas 76508 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| Carilion Medical Center for Children | Roanoke, Virginia 24029 |
| West Virginia University - Charleston | Charleston, West Virginia 25302 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
| Lutheran General Hospital | Park Ridge, Illinois 60068 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Mountain States Tumor Institute | Boise, Idaho 83712 |
| Albert Einstein Clinical Cancer Center | Bronx, New York 10461 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Children's Hospital Central California | Madera, California 93638-8762 |
| Children's Hospital of Oakland | Oakland, California 94609-1809 |
| Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
| Santa Barbara Cottage Hospital | Santa Barbara, California 93102 |
| Presbyterian-St Luke's Medical Center | Denver, Colorado 80218 |
| University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
| Alfred I. Dupont Institute | Wilmington, Delaware 19899 |
| University of Miami-Jackson Memorial Hospital | Miami, Florida 33136 |
| Medical Center of Central Georgia | Macon, Georgia 31201 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
| Raymond Blank Memorial Hospital for Children | Des Moines, Iowa 50308 |
| Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
| Spectrum Health and DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
| St. Mary's/Duluth Clinic Cancer Center | Duluth, Minnesota 55805-1983 |
| Children's Hospitals and Clinics - Minneapolis | Minneapolis, Minnesota 55404 |
| St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
| Children's Hospital of Omaha | Omaha, Nebraska 68114 |
| Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
| Atlantic Health System | Summit, New Jersey 07901 |
| Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
| Brooklyn Hospital Center | Brooklyn, New York 11201 |
| State University of New York Health Science Center at Brooklyn College of Medicine | Brooklyn, New York 11203 |
| Maimonides Medical Center | Brooklyn, New York 11219 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
| Children's Medical Center - Dayton | Dayton, Ohio 45404 |
| Toledo Children's Hospital | Toledo, Ohio 43601 |
| Forum Health-Tod Childrens Hospital | Youngstown, Ohio 44501 |
| Children's Hospital of Oklahoma | Oklahoma City, Oklahoma 73104 |
| Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
| Palmetto Health South Carolina Cancer Center | Columbia, South Carolina 29203 |
| Sioux Valley Hospital | Sioux Falls, South Dakota 57117 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
| Covenant Children's Hospital | Lubbock, Texas 79410 |
| Methodist Health Care System | San Antonio, Texas 78229-3902 |
| Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
| Group Health Cooperative | Seattle, Washington 98112 |
| Cabell-Huntington Hospital, Inc | Huntington, West Virginia 25701 |
| Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
| Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| Children's Hospitals and Clinics - Minnesota | Saint Paul, Minnesota 55102 |
| Walt Disney Memorial Cancer Institute at Florida Hospital | Orlando, Florida 32803 |
| Medical College of Ohio Hospital | Madison, Wisconsin 53792-6164 |
