Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas (NCT00012181) | Clinical Trial Compass
CompletedPhase 1
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
United States30 participantsStarted 2001-04
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 rec…
What they're measuring
1
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0