Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed … (NCT00005952) | Clinical Trial Compass
CompletedPhase 1/2
Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors
United States30 participantsStarted 2000-08
Plain-language summary
RATIONALE: 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/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
Who can participate
Age range18 Years
SexALL
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 confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR
* Histologically confirmed non-CNS tumor
* Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma)
* Recurrent or resistant neuroblastoma
* Recurrent Wilm's tumor
* Recurrent Ewing's sarcoma
* Recurrent primitive neuroectodermal tumors
* Recurrent nasopharyngeal carcinoma
* Recurrent germ cell tumor
* Expected cure rate less than 10% with standard therapy
* Measurable and/or active disease
* History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and under
Performance status:
* Karnofsky 70-100% OR
* Lansky 70-100%
Life expectancy:
* Greater than 8 weeks
Hematopoietic:
* Reasonably cellular bone marrow (greater than 15% cellularity on biopsy)
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 75,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* SGPT less than 120 U/L
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram
Pulmonary:
* CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patient…