Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors
|ClinicalTrials.gov Identifier: NCT00003811|
Recruitment Status : Completed
First Posted : December 10, 2003
Last Update Posted : July 4, 2013
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|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|
- Feasibility from Efficacy StandpointThe 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.
- Assessment of Reduction in ToxicityDescriptive 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003811
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|Study Chair:||Neyssa M. Marina, MD||Stanford University|