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 range35 Years
SexALL
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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…
Trial details
NCT IDNCT00007813
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins