- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00012181
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
Study Overview
Status
Conditions
- Unspecified Childhood Solid Tumor, Protocol Specific
- Recurrent Childhood Medulloblastoma
- Recurrent Childhood Ependymoma
- Recurrent Neuroblastoma
- Recurrent Osteosarcoma
- Recurrent Childhood Rhabdomyosarcoma
- Recurrent Wilms Tumor and Other Childhood Kidney Tumors
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Childhood Large Cell Lymphoma
- Recurrent Childhood Lymphoblastic Lymphoma
- Recurrent Childhood Small Noncleaved Cell Lymphoma
- Recurrent/Refractory Childhood Hodgkin Lymphoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Liver Cancer
- Recurrent Childhood Brain Stem Glioma
- Recurrent Childhood Cerebellar Astrocytoma
- Recurrent Childhood Cerebral Astrocytoma
- Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
- Recurrent Childhood Visual Pathway and Hypothalamic Glioma
- Recurrent Childhood Visual Pathway Glioma
- Recurrent Retinoblastoma
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Arcadia, California, United States, 91006-3776
- COG Phase I Consortium
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
Given IV
Other Names:
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Whitlock, COG Phase I Consortium
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Disease Attributes
- Retinal Diseases
- Genetic Diseases, Inborn
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Eye Diseases, Hereditary
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Leukemia, Lymphoid
- Leukemia
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Eye Neoplasms
- Retinal Neoplasms
- Myosarcoma
- Neoplasms
- Sarcoma
- Lymphoma
- Recurrence
- Lymphoma, Non-Hodgkin
- Glioma
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Sarcoma, Ewing
- Ependymoma
- Medulloblastoma
- Osteosarcoma
- Astrocytoma
- Neuroblastoma
- Retinoblastoma
- Rhabdomyosarcoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Wilms Tumor
- Neuroectodermal Tumors, Primitive, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Alvocidib
Other Study ID Numbers
- NCI-2012-01854
- U01CA097452 (U.S. NIH Grant/Contract)
- ADVL0017
- CCG-AO972
- CDR0000068491
- COG-ADVL0017
- NCI-A0972
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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