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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.
 
ClinicalTrials.gov Identifier: NCT00012181
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 3, 2001
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE April 2001
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Official Title  ICMJE A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
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.
Detailed Description

PRIMARY OBJECTIVES:

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: alvocidib
    Given IV
    Other Names:
    • FLAVO
    • flavopiridol
    • HMR 1275
    • L-868275
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Study Arms  ICMJE 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.
Interventions:
  • Drug: alvocidib
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2013)
30
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Australia,   Canada
 
Administrative Information
NCT Number  ICMJE NCT00012181
Other Study ID Numbers  ICMJE NCI-2012-01854
ADVL0017
CCG-AO972
CDR0000068491
COG-ADVL0017
NCI-A0972
U01CA097452 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Whitlock COG Phase I Consortium
PRS Account National Cancer Institute (NCI)
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP