Clinical trial · Interventional
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
NCT00012181CI-TRIAL-00011195completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Brain Stem Glioma | Childhood Brain Stem Glioma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Cerebellar Astrocytoma | Childhood Cerebellar Astrocytoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Cerebral Astrocytoma | Childhood Cerebral Astrocytoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Ependymoma | Childhood Ependymoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Large Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Childhood Liver Cancer | Childhood Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Childhood Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Childhood Malignant Germ Cell Tumor | Childhood Malignant Germ Cell Tumor | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (alvocidib)
- description
- 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.
- interventionNames
- Drug: alvocidib
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0
- timeFrame
- Day 21
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.