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High-dose Chemotherapy for Testicular Cancer
Study Summary
This trial is looking at whether 2 cycles of high-dose chemotherapy can help control germ-cell tumors, and what the side effects of the drug combinations are.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2010 Phase 2 & 3 trial • 135 Patients • NCT00176904Trial Design
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- You have received radiation treatment to your entire brain before.If you have a type of cancer called nonseminomatous germ cell tumor and experience growing teratoma syndrome during chemotherapy, you will not be able to participate.You have a serious infection that needs to be treated with antibiotics given through a needle or a tube.A female who could get pregnant has a positive pregnancy test.Your kidneys work well enough, and your urine protein levels are within a certain range.Your liver is working well, as shown by specific blood test results for ALT, AST, bilirubin, and alkaline phosphatase.You need to have good lung function as measured by specific breathing tests.People between the ages of 12 and 65 years old.You have an ongoing brain or spinal cord condition that is not under control.You have active hepatitis B or advanced liver disease from chronic hepatitis C.You have a certain type of germ-cell tumor that has come back or responded in a certain way to treatment.You have HIV, unless you are taking medicine that is working well to control the virus and your immune system is healthy.You had a stem cell transplant in the last year.You are able to carry out your daily activities with little to no difficulty.Your heart is working well and you don't have any serious heart problems or irregular heartbeats.You need to have at least 5 million CD34+ cells per kilogram of your own hematopoietic progenitor cells collected through apheresis.
- Group 1: Cycle # 1
- Group 2: Cycle #2
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is it possible for me to take part in this clinical investigation?
"This medical experiment is looking to recruit 64 individuals between the ages of 12 and 65 who have testiculate cancer. To be considered, candidates should satisfy these conditions: Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model., B) Second relapse or beyond.; Male/female patients within a specified age bracket; Zubrod performance status 0-2; Adequate cardiac function with LVEF (left ventricular ejection fraction) >/="
What potential hazards should patients be aware of when considering a Stem Cell Transplant?
"Using a scale from 1 to 3, our team at Power judged the safety of Stem Cell Transplant as a 2. This is due to Phase 2 trial data that suggests some level of security but no evidence related to effectiveness."
Is the target demographic for this trial comprised of individuals over fifty years old?
"The available data on this clinical trial specifies that the age range for enrollment is between 12 and 65."
Has there been any precedent for utilizing stem cell transplantation in clinical trials?
"Stem Cell Transplant was first analysed back in 1997 at City of Hope Comprehensive Cancer Center and there have been 2826 completed studies since then. At present, 1577 clinical trials are actively recruiting participants, with a considerable number located in Seattle, Washington."
Does this research venture still accept new participants?
"Data hosted on clinicaltrials.gov suggests that this medical study is no longer seeking participants, as the most recent update was posted on May 5th 2022. Nevertheless, a total of 1653 other trials are currently enrolling patients at this moment in time."
What maladies has Stem Cell Transplant been utilized to ameliorate?
"Stem Cell Transplant is an established form of treatment for Merkel cell cancer, primary bladder cancer and metastatic bladder cancer."
How many participants have been recruited to partake in this scientific experiment?
"This clinical trial is no longer in the recruitment phase. It was originally posted on June 2nd 2009 and has seen its most recent update May 5th 2022. Thankfully, there are many other trials taking place; 76 studies actively recruiting patients with testicular cancer and 1577 for stem cell transplantation specifically."
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