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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003811
Recruitment Status : Completed
First Posted : December 10, 2003
Last Update Posted : July 4, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Childhood Germ Cell Tumor Drug/Agent Toxicity by Tissue/Organ Extragonadal Germ Cell Tumor Ovarian Cancer Biological: bleomycin sulfate Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Procedure: conventional surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Primary Purpose: Treatment
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
Study Start Date : April 2000
Actual Primary Completion Date : October 2004
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003811

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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Study Chair: Neyssa M. Marina, MD Stanford University
Publications of Results:
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Responsible Party: Children's Oncology Group Identifier: NCT00003811    
Other Study ID Numbers: 9749
POG-9749 ( Other Identifier: Pediatric Oncology Group )
CDR0000066956 ( Other Identifier: Clinical )
First Posted: December 10, 2003    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013
Keywords provided by Children's Oncology Group:
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
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Drug-Related Side Effects and Adverse Reactions
Neoplasms by Histologic Type
Chemically-Induced Disorders
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs