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Childhood Germ Cell TumorPhase 2NCT00003811

Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

A Phase 2 study testing bleomycin sulfate, amifostine trihydrate and cisplatin in people with Childhood Germ Cell Tumor and Drug/Agent Toxicity by Tissue/Organ, run by Children's Oncology Group at 110 sites in 6 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

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Read more about this study

Who is it for?
Ages Up to 14 years
What is being tested?
bleomycin sulfate, amifostine trihydrate and cisplatin
Type of treatment
Surgery or procedure
How many people
27 participants
Where
110 sitesin 6 countries
Study dates
Apr 2000to Sep 2007
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 14 years
  • All sexes
  • No healthy volunteers
  • Child

DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk, extracranial germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor) Embryonal carcinoma Choriocarcinoma Teratoma with mixed malignant elements (malignant teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I extracranial, extragonadal tumor High-risk disease defined as stage III or IV extragonadal tumors Measurable disease by diagnostic imaging

PATIENT CHARACTERISTICS: Age: Under 15 at time of diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 750/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine normal OR Glomerular filtration rate at least 50% of normal

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Trial locations and contacts

110 sites in 6 countries.

110 sites in 6 countries

United States97 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • Mission Saint Joseph's Health System

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • 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, 35294-3300

  • Boston Floating Hospital Infants and Children

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University Medical School-Charleston

    Charleston, West Virginia, 25304

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60612

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • St. John's Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Hurley Medical Center

    Flint, Michigan, 48503

  • 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, 77555-0209

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • James H. Quillen College of Medicine

    Johnson City, Tennessee, 37614-0622

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32803

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Maine Children's Cancer Program

    Portland, Maine, 04101

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Roanoke Community Hospital

    Roanoke, Virginia, 24029

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • MBCCOP - South Texas Pediatric

    San Antonio, Texas, 78229-3900

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Children's Hospital and Health Center

    San Diego, California, 92123-4282

  • Naval Medical Center - San Diego

    San Diego, California, 92134-3202

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305-5408

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

    Stony Brook, New York, 11790-7775

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • CCOP - Florida Pediatric

    Tampa, Florida, 33682-7757

  • Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • Walter Reed Army Medical Center

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

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada8 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • 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

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Switzerland2 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Clinique de Pediatrie

    Geneva, 1211

Other trials in Switzerland

Australia1 site

  • Royal Children's Hospital

    Parkville, Victoria, 3052

Other trials in Australia

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

About this study

Official title: High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study

RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and bleomycin plus amifostine in treating children who have malignant germ cell tumors.

Read the detailed description

OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin, etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant, extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the hematologic and nonhematologic toxic effects of this combination chemotherapy in these patients when compared to similar patients treated on POG-9049/CCG-8881 with the same combination chemotherapy. III. Determine the response rate of patients treated with this regimen.

OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. Patients who have no disease after 4 courses of chemotherapy receive no further treatment. Patients who have residual disease undergo second-look surgery. After surgery, patients who still have active tumor receive 2 additional courses of chemotherapy. Those patients who still have tumor after the 2 additional courses may have a third surgery. Patients are followed every month for 6 months, every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until death.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.

Being tested
bleomycin sulfate, amifostine trihydrate, cisplatin, etoposide, conventional surgery
Keywords
drug/agent toxicity by tissue/organ, childhood teratoma, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood extragonadal germ cell tumor, recurrent childhood malignant germ cell tumor
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Ovarian Neoplasms, Teratoma, Testicular Neoplasms, Ovarian Germ Cell Cancer

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility from Efficacy Standpoint

    The hazard rate is constant over 1.39 years, then the probability of the occurrence of a failure within this time interval follows a Poisson distribution. The table below shows the trial feasibility probabilities associated with those failure rates. We define the probability of feasibility as the probability of observing a total of at most less than three failures in 25 patient years of follow-up.

Secondary outcomes (1)

  1. Assessment of Reduction in Toxicity

    Descriptive statistics will be performed for nephrotoxicity, hematologic and pulmonary toxicities, and inference will be performed for ototoxicity. Frequency tables of the occurrences of toxicities by grade will be tabulated for ANC and platelets. To assess nephrotoxicity and pulmonary toxicity, descriptive statistics will be calculated for GFR and DLCO, respectively. These statistics will be compared to the corresponding summaries on the appropriate population of patients from POG 9049/CCG 8881.

Timeline

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

  1. First posted10 Dec 2003 (estimated)
  2. Study startApr 2000
  3. Primary completionOct 2004
  4. Study completionSep 2007

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
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003811
Sponsor's protocol ID
9749
Other IDs
POG-9749, CDR0000066956
Status last verified
Jul 2013
First submitted
1 Nov 1999
Last updated
4 Jul 2013
Results posted
No

Publications

  • Marina N, Chang KW, Malogolowkin M, London WB, Frazier AL, Womer RB, Rescorla F, Billmire DF, Davis MM, Perlman EJ, Giller R, Lauer SJ, Olson TA; Children's Oncology Group. Amifostine does not protect against the ototoxicity of high-dose cisplatin combined with etoposide and bleomycin in pediatric germ-cell tumors: a Children's Oncology Group study. Cancer. 2005 Aug 15;104(4):841-7. doi: 10.1002/cncr.21218.

    PubMed 15999362

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bleomycin sulfate, amifostine trihydrate and cisplatin in people with Childhood Germ Cell Tumor and Drug/Agent Toxicity by Tissue/Organ, run by Children's Oncology Group at 110 sites in 6 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 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Canada, Switzerland, Australia, Netherlands and 1 more country. 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.

What does the primary outcome measure?

Feasibility from Efficacy Standpoint. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003811, 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 4 Jul 2013.

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