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Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
This study is ongoing, but not recruiting participants.
Study NCT00012181   Information provided by National Cancer Institute (NCI)
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes

March 3, 2001
July 23, 2008
April 2001
 
 
 
Complete list of historical versions of study NCT00012181 on ClinicalTrials.gov Archive Site
 
 
 
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Phase I Study Of Flavopiridol (NSC# 649890; IND # 46211) In Patients With Relapsed Or Refractory Pediatric Solid Tumors Or Lymphomas

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating children who have relapsed or refractory solid tumors or lymphoma.

OBJECTIVES:

  • Determine the maximum tolerated dose of flavopiridol in children with relapsed or refractory solid tumors or lymphomas.
  • Determine the toxic effects and pharmacokinetics of this drug in these patients.
  • 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.

Phase I
Interventional
Treatment
  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Kidney Cancer
  • Liver Cancer
  • Lymphoma
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
Drug: alvocidib
 
Whitlock JA, Krailo M, Reid JM, Ruben SL, Ames MM, Owen W, Reaman G; Children's Oncology Group Study. Phase I clinical and pharmacokinetic study of flavopiridol in children with refractory solid tumors: a Children's Oncology Group Study. J Clin Oncol. 2005 Dec 20;23(36):9179-86.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Under 22

Performance status:

  • Karnofsky 50-100% (over age 10)
  • Lansky 50-100% (age 10 and under)

Life expectancy:

  • At least 2 months

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGPT no greater than 5 times normal
  • Albumin at least 2 g/dL

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal

Cardiovascular:

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • 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

Chemotherapy:

  • At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No other concurrent chemotherapy

Endocrine therapy:

  • 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

Radiotherapy:

  • 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

Surgery:

  • Not specified

Other:

  • No concurrent anticonvulsants
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00012181
 
CDR0000068491, COG-ADVL0017, CCG-AO972, NCI-A0972
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: James A. Whitlock, MD Vanderbilt Children's Hospital
National Cancer Institute (NCI)
April 2003

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