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Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas

This study has been completed.
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: March 3, 2001
Last updated: July 1, 2013
Last verified: July 2013
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.

Condition Intervention Phase
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 Drug: alvocidib Other: pharmacological study Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0 [ Time Frame: Day 21 ]

Enrollment: 30
Study Start Date: April 2001
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: alvocidib
Given IV
Other Names:
  • flavopiridol
  • HMR 1275
  • L-868275
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed Description:


I. Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.

II. Determine the toxic effects and pharmacokinetics of this drug in these patients.

III. Determine the antitumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

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.

Cohorts of 3 to 6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 18 months.


Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00012181

United States, California
COG Phase I Consortium
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: James Whitlock COG Phase I Consortium
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00012181     History of Changes
Other Study ID Numbers: NCI-2012-01854
U01CA097452 ( US NIH Grant/Contract Award Number )
Study First Received: March 3, 2001
Last Updated: July 1, 2013

Additional relevant MeSH terms:
Hodgkin Disease
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Liver Neoplasms
Neoplasms, Germ Cell and Embryonal
Wilms Tumor
Rhabdomyosarcoma, Embryonal
Sarcoma, Ewing
Lymphoma, Non-Hodgkin
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Optic Nerve Glioma
Kidney Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue processed this record on June 23, 2017