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

Primary Purpose

Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
alvocidib
pharmacological study
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Childhood Brain Stem Glioma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • COG Phase I Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (alvocidib)

Arm Description

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.

Outcomes

Primary Outcome Measures

MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using Common Toxicity Criteria version 2.0

Secondary Outcome Measures

Full Information

First Posted
March 3, 2001
Last Updated
July 1, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00012181
Brief Title
Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
Official Title
A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (alvocidib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
alvocidib
Other Intervention Name(s)
FLAVO, flavopiridol, HMR 1275, L-868275
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Whitlock
Organizational Affiliation
COG Phase I Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
COG Phase I Consortium
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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

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