Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid … (NCT00007813) | Clinical Trial Compass
CompletedPhase 1
Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors
United States21 participantsStarted 1997-05-31
Plain-language summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cyclophosphamide when given together with combination chemotherapy and a peripheral stem cell transplant in treating patients with malignant solid tumors.
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven malignant solid tumor, including any of the following:
* Rhabdomyosarcoma
* Neuroblastoma
* Ewing's sarcoma/primitive neuroectodermal tumor
* Germ cell tumors
* Childhood brain tumors
* Hepatoblastoma
* Metastatic disease OR has failed at least first-line therapy
* Ineligible for higher priority protocols
PATIENT CHARACTERISTICS:
Age:
* Under 36 at transplantation
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm3
* Platelet count at least 75,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* Liver function tests no greater than 2 times normal OR
* No active hepatitis on liver biopsy
* No hepatitis B infection
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Glomerular filtration rate (preferably measured) greater than 60% of normal
Cardiovascular:
* Left ventricular ejection fraction at least 45%
* No active congestive heart failure
* No active arrhythmia
Pulmonary:
* Age 8 and under: clinically normal pulmonary function
* Over age 8: FEV1 and FVC at least 50% predicted
* Arterial blood gases normal and DLCO at least 50% if spirograms difficult to
* interpret due to poor patient effort, recent surgery, or pulmonary tumor
* involvement
Other:
* No mucositis or mucosal infection prior to myeloablative chemotherapy
* HIV negative
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00007813
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins