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Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
This study is ongoing, but not recruiting participants.
First Received: March 3, 2001   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00012181
  Purpose

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.


Condition Intervention Phase
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
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study Of Flavopiridol (NSC# 649890; IND # 46211) In Patients With Relapsed Or Refractory Pediatric Solid Tumors Or Lymphomas

Resource links provided by NLM:


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

Study Start Date: April 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Show 51 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: James A. Whitlock, MD Vanderbilt Children's Hospital
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000068491, COG-ADVL0017, CCG-AO972, NCI-A0972
Study First Received: March 3, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00012181     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood rhabdomyosarcoma
recurrent neuroblastoma
recurrent childhood liver cancer
recurrent Wilms tumor and other childhood kidney tumors
recurrent retinoblastoma
recurrent childhood lymphoblastic lymphoma
recurrent osteosarcoma
unspecified childhood solid tumor, protocol specific
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood soft tissue sarcoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma
recurrent childhood brain stem glioma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood visual pathway glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent childhood ependymoma
recurrent childhood malignant germ cell tumor

Study placed in the following topic categories:
Retinal Neoplasms
Liver Diseases
Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Central Nervous System Neoplasms
Retinoblastoma
Urologic Neoplasms
Protein Kinase Inhibitors
Neoplasms, Connective and Soft Tissue
Wilms' Tumor
Osteogenic Sarcoma
Neuroepithelioma
Glioma
Kidney Diseases
Hodgkin Disease
Nervous System Neoplasms
Rhabdomyosarcoma
Lymphoma, Large B-Cell, Diffuse
Digestive System Neoplasms
Immunoproliferative Disorders
Astrocytoma
Eye Neoplasms
Ewing's Sarcoma
Carcinoma
Neuroectodermal Tumors
Brain Stem Glioma, Childhood
Malignant Mesenchymal Tumor
Sarcoma
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Retinal Neoplasms
Liver Diseases
Neuroectodermal Tumors, Primitive
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Central Nervous System Neoplasms
Retinoblastoma
Urologic Neoplasms
Protein Kinase Inhibitors
Neuroblastoma
Liver Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Growth Inhibitors
Kidney Diseases
Lymphoma
Retinal Diseases
Nervous System Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Digestive System Neoplasms
Eye Neoplasms
Immune System Diseases

ClinicalTrials.gov processed this record on July 02, 2009