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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00012181
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2001
Actual Primary Completion Date : January 2005

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00012181

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United States, California
COG Phase I Consortium
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: James Whitlock COG Phase I Consortium
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00012181    
Other Study ID Numbers: NCI-2012-01854
U01CA097452 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Lymphoma, Non-Hodgkin
Wilms Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Leukemia, Lymphoid