Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma
About this trial
This is an interventional treatment trial for Recurrent Childhood Brain Stem Glioma
Eligibility Criteria
Inclusion Criteria: 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 CNS toxicity less than grade 2 No active graft-versus-host disease No active uncontrolled infection or other serious medical condition No uncontrolled diabetes mellitus Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 7 days since prior biologic therapy and recovered Prior bone marrow or stem cell transplantation allowed At least 6 months since prior allogeneic stem cell transplantation At least 1 week since prior growth factors No concurrent immunomodulating agents At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered No other concurrent chemotherapy Concurrent dexamethasone for CNS tumors allowed if on stable dose for at least 2 weeks prior to study Concurrent corticosteroids allowed only for increased intracranial pressure in patients with CNS tumors At least 2 weeks since prior local (small port) palliative radiotherapy At least 6 months since prior radiotherapy to 50% or more of the pelvis At least 6 months since prior craniospinal radiotherapy At least 6 weeks since other prior substantial bone marrow radiotherapy Recovered from prior radiotherapy No concurrent radiotherapy except localized palliative radiotherapy No concurrent anticonvulsants
Sites / Locations
- COG Phase I Consortium
Arms of the Study
Arm 1
Experimental
Treatment (alvocidib)
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.