Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Completed · Phase 1
Conditions studied: Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Liver Cancer, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Malignant Germ Cell Tumor, Recurrent Childhood Medulloblastoma, Recurrent Childhood Rhabdomyosarcoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Recurrent Childhood Visual Pathway Glioma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Neuroblastoma, Recurrent Osteosarcoma, Recurrent Retinoblastoma, Recurrent Wilms Tumor and Other Childhood Kidney Tumors, Recurrent/Refractory Childhood Hodgkin Lymphoma, Unspecified Childhood Solid Tumor, Protocol Specific
In brief
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.
Key facts
- Study ID
- NCT00012181
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2001-04-01
- Last updated by the study team
- 2013-07-02
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma
- Rhabdomyosarcoma
- Wilms tumor
- CNS tumors
- Histological verification not required for brainstem tumors
- No acute leukemia
- Not eligible for higher priority COG phase I/II study
- Performance status - Karnofsky 50-100% (over age 10)
- Performance status - Lansky 50-100% (age 10 and under)
- At least 2 months
- Absolute neutrophil count at least 1,000/mm\^3
- Platelet count at least 75,000/mm\^3 (transfusion independent)
- Hemoglobin at least 8.0 g/dL (transfusion allowed)
- No granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow involvement
- Bilirubin no greater than 1.5 times normal
- SGPT no greater than 5 times normal
- Albumin at least 2 g/dL
- Creatinine no greater than 1.5 times normal
- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal
- Shortening fraction at least 27% by echocardiogram
- Ejection fraction at least 50% by MUGA
- Stable neurologic deficits within the past 2 weeks for patients with CNS tumors
Where it is running
- COG Phase I Consortium — Arcadia, California, United States
Full record on ClinicalTrials.gov
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