Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006515
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2000-11-21
Brief Title:
Late Effects of Treatment for Sarcomas in Children
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Late Effects of Treatment in Survivors of Pediatric Sarcomas
Status:
COMPLETED
Status Verified Date:
2011-11-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine late effects of treatment for sarcoma bone and soft tissue cancers in children Survival of patients with these diseases has improved over the years but long-term adverse effects of treatment have also been noted
Patients previously treated for sarcoma in the NCIs Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment chemotherapy radiation therapy cancer related surgery or immunotherapy for at least 24 months may be eligible for this 3- to 4-day study It will review the incidence and extent of the following late effects of therapy
Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle Patients will undergo magnetic resonance imaging MRI of the heart to look for changes and compare the findings with information obtained by standard echocardiogram ultrasound test of the heart and by MUGA nuclear medicine scan of the heart
Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production leading to infertility early menopause or brittle bones Low sex hormone levels may also increase the risk for heart attack obesity or fracture Patients will have blood tests to measure hormone levels as well as mineral levels lipid levels and blood cell counts They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen Males will be offered a semen analysis as part of the fertility evaluation
Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships jobs insurance education health care and personal and professional goal setting Some patients may become depressed or develop a psychiatric illness Patients will fill out a questionnaire about their treatment recovery and aspects of their current life and will meet with a psychologist and psychiatrist
Changes in bodily function and capabilities-Patients who undergo surgery and radiation to treat sarcoma treatment may experience muscle bone and joint changes Patients will be interviewed about their performance of daily activities physical limitations and changes in skill levels They will do a series of exercises and will have measurements of strength mobility and physical skills focusing on the parts of the body that were affected by the sarcoma and subsequent local therapy
Exposure to viruses-A number of patients received blood transfusions as part of their cancer treatment Some transfusions were given before HIV screening became available Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 human T-cell leukemia virus-1 for which there are also small transfusion-associated risks
Kidney function-The chemotherapy drug ifosfamide may affect kidney function Patients will provide a urine specimen for kidney function tests
Immune function-Chemotherapy affects the function of infection-fighting immune cells called T-lymphocytes A blood sample will be drawn for studies of the time involved in recovering full immune function
Patients previously treated for sarcoma in the NCIs Pediatric Oncology Branch who are in their first remission from sarcoma after completion of therapy and who have had no further cancer treatment chemotherapy radiation therapy cancer related surgery or immunotherapy for at least 24 months may be eligible for this 3- to 4-day study It will review the incidence and extent of the following late effects of therapy
Heart problems-The chemotherapy drug doxorubicin can cause acute and late injuries to the heart muscle Patients will undergo magnetic resonance imaging MRI of the heart to look for changes and compare the findings with information obtained by standard echocardiogram ultrasound test of the heart and by MUGA nuclear medicine scan of the heart
Gonadal dysfunction-The chemotherapy drug cyclophosphamide may affect sex hormone production leading to infertility early menopause or brittle bones Low sex hormone levels may also increase the risk for heart attack obesity or fracture Patients will have blood tests to measure hormone levels as well as mineral levels lipid levels and blood cell counts They will also have a DEXA scan to measure bone mineral density and a CT scan of the abdomen to evaluate the distribution of fatty tissue in the abdomen Males will be offered a semen analysis as part of the fertility evaluation
Psychosocial problems- Cancer diagnosis and treatment pose a major life stress that can lead to problems with personal relationships jobs insurance education health care and personal and professional goal setting Some patients may become depressed or develop a psychiatric illness Patients will fill out a questionnaire about their treatment recovery and aspects of their current life and will meet with a psychologist and psychiatrist
Changes in bodily function and capabilities-Patients who undergo surgery and radiation to treat sarcoma treatment may experience muscle bone and joint changes Patients will be interviewed about their performance of daily activities physical limitations and changes in skill levels They will do a series of exercises and will have measurements of strength mobility and physical skills focusing on the parts of the body that were affected by the sarcoma and subsequent local therapy
Exposure to viruses-A number of patients received blood transfusions as part of their cancer treatment Some transfusions were given before HIV screening became available Patients will be tested for this virus as well as the hepatitis virus and HTLV-1 human T-cell leukemia virus-1 for which there are also small transfusion-associated risks
Kidney function-The chemotherapy drug ifosfamide may affect kidney function Patients will provide a urine specimen for kidney function tests
Immune function-Chemotherapy affects the function of infection-fighting immune cells called T-lymphocytes A blood sample will be drawn for studies of the time involved in recovering full immune function
Detailed Description:
Childhood cancers mark a relatively infrequent disease entity with an annual age adjusted rate in children age 0-14 years of 14 per 100000 Over the last 30 years a striking increase in survival due to improved diagnosis and aggressive treatment approaches has vastly enhanced the outlook in this patient population 75 of children under 15 years age of can be expected to survive the diagnosis of cancer for more than 5 years However reports of improved survival have been followed by increasing awareness of a multitude of long-term treatment-related side effects in addition to an overall death rate 96 times higher than in the sex- and age-matched general population Over the last 35 years patients with pediatric sarcomas have been treated in the Pediatric Oncology Branch POB of the National Cancer Institute Since 1971 adriamycin and cyclophosphamide in escalating doses have been incorporated in all multimodality treatment protocols Ifosfamide became an integral part of therapy in 1986 The survival rate of patients with these diseases has improved over this period of time Accordingly there exists a group of long-term survivors of therapy employed in a series of POB sarcoma protocols who represent a valuable source of information on treatment-associated late-effects eg cardiotoxicity gonadal dysfunction growth delay and stress-related neuroendocrine abnormalities In addition there may be evaluable rehabilitative impairments and alterations in psychosocial behavior that may only manifest over time and prove to be characteristic for this population This protocol will systematically enumerate and describe the incidence and extent of treatment related long-term toxicities in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-C-0037 | None | None | None |