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Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: May 9, 2009   History of Changes
Sponsors and Collaborators: Pediatric Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003811
  Purpose

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 Intervention 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 I

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 25
Study Start Date: April 2000
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003811

  Show 110 Study Locations
Sponsors and Collaborators
Pediatric Oncology Group
Investigators
Study Chair: Neyssa M. Marina, MD Stanford University
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000066956, POG-9749
Study First Received: November 1, 1999
Last Updated: May 9, 2009
ClinicalTrials.gov Identifier: NCT00003811     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Radiation-Protective Agents
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Etoposide phosphate
Genital Diseases, Female
Anti-Bacterial Agents
Cisplatin
Neoplasms, Germ Cell and Embryonal
Ovarian Cancer
Etoposide
Endocrine Gland Neoplasms
Extragonadal Germ Cell Tumor
Ovarian Neoplasms
Testicular Cancer
Amifostine
Malignant Germ Cell Tumor
Genital Neoplasms, Female
Endocrine System Diseases
Testicular Neoplasms
Bleomycin
Recurrence
Radiation-Sensitizing Agents
Endocrinopathy
Antineoplastic Agents, Phytogenic
Teratoma

Additional relevant MeSH terms:
Radiation-Protective Agents
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Ovarian Neoplasms
Amifostine
Genital Neoplasms, Female
Endocrine System Diseases
Bleomycin
Protective Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 02, 2009