AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 2NCT00006102

Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma

A Phase 2 study testing becatecarin in people with Brain and Central Nervous System Tumors and Lymphoma, run by National Cancer Institute (NCI) at 226 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
becatecarin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
226 sitesin 7 countries
Study dates
Jul 2000to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

226 sites in 7 countries.

226 sites in 7 countries

United States198 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Mission St. Joseph's Health System

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Children's Healthcare of Atlanta - Scottish Rite

    Atlanta, Georgia, 30342

  • Medical College of Georgia Comprehensive Cancer Center

    Augusta, Georgia, 30912-4000

  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201-1595

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201

  • State University of New York Health Science Center at Brooklyn College of Medicine

    Brooklyn, New York, 11203

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Charleston

    Charleston, West Virginia, 25302

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60601

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Children's Hospital Medical Center - Cincinnati

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Children's Hospital of Columbus

    Columbus, Ohio, 43205-2696

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404

  • Children's Hospital of Denver

    Denver, Colorado, 80218

  • Presbyterian-St Luke's Medical Center

    Denver, Colorado, 80218

  • Raymond Blank Memorial Hospital for Children

    Des Moines, Iowa, 50308

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's/Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805-1983

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Michigan State University

    East Lansing, Michigan, 48824

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Dakota Cancer Institute

    Fargo, North Dakota, 58103-4940

  • University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Spectrum Health and DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Cabell-Huntington Hospital, Inc

    Huntington, West Virginia, 25701

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at JCMC

    Johnson City, Tennessee, 37604

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109-2306

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0284

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801-1428

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-3830

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • Medical College of Ohio Hospital

    Madison, Wisconsin, 53792-6164

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5772

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • University of Miami-Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155-4069

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of South Alabama Medical Center

    Mobile, Alabama, 36604

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021-4885

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital of Oakland

    Oakland, California, 94609-1809

  • Children's Hospital of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Walt Disney Memorial Cancer Institute at Florida Hospital

    Orlando, Florida, 32803

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Lutheran General Hospital

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Doernbecher Children's Hospital

    Portland, Oregon, 97201-3098

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Medical Center for Children

    Roanoke, Virginia, 24029

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Children's Hospitals and Clinics - Minnesota

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • Methodist Health Care System

    San Antonio, Texas, 78229-3902

  • 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 - San Francisco Geary Campus

    San Francisco, California, 94115

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0128

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Cooperative

    Seattle, Washington, 98112

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-1080

  • Sioux Valley Hospital

    Sioux Falls, South Dakota, 57117

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9658

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Atlantic Health System

    Summit, New Jersey, 07901

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • Tampa Children's Hospital

    Tampa, Florida, 33677-4227

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • Toledo Children's Hospital

    Toledo, Ohio, 43601

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

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

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. Dupont Institute

    Wilmington, Delaware, 19899

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Forum Health-Tod Childrens Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada15 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • Children's Hospital of Western Ontario

    London, Ontario, N6C 2V5

  • McGill University Health Center - Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Laval University Medical Center

    Sainte-Foy, Quebec, G1V 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6006

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, CH 1011

Other trials in Switzerland

Puerto Rico2 sites

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9700 RB

Other trials in Netherlands

New Zealand1 site

  • Starship Children's Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors

Phase II trial to study the effectiveness of rebeccamycin analogue in treating children who have solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
becatecarin
Keywords
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
Medical subject headings
Central Nervous System Neoplasms, Lymphoma, Neuroblastoma, Retinoblastoma, Sarcoma, Astrocytoma, Oligodendroglioma, Choroid Plexus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • becatecarinDrug

Study groups in NCT00006102
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: becatecarin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2000
  3. Primary completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006102
Sponsor's protocol ID
NCI-2012-01851
Other IDs
COG-P9963, CDR0000068111
Status last verified
Nov 2010
First submitted
3 Aug 2000
Last updated
5 Feb 2013
Results posted
No

Publications

  • Langevin AM, Bernstein M, Kuhn JG, Blaney SM, Ivy P, Sun J, Chen Z, Adamson PC; Children's Oncology Group. A phase II trial of rebeccamycin analogue (NSC #655649) in children with solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2008 Mar;50(3):577-80. doi: 10.1002/pbc.21274.

    PubMed 17610262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing becatecarin in people with Brain and Central Nervous System Tumors and Lymphoma, run by National Cancer Institute (NCI) at 226 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006102, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.

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