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A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS


Phase 1
N/A
21 Years
Open (Enrolling)
Both
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

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Trial Information

A PHASE I STUDY OF FLAVOPIRIDOL (NSC# 649890; IND# 46211) IN PATIENTS WITH RELAPSED OR REFRACTORY PEDIATRIC SOLID TUMORS OR LYMPHOMAS


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Day 21

Safety Issue:

Yes

Principal Investigator

James Whitlock

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01854

NCT ID:

NCT00012181

Start Date:

April 2001

Completion Date:

Related Keywords:

  • 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
  • Astrocytoma
  • Ependymoma
  • Glioma
  • Hodgkin Disease
  • Kidney Neoplasms
  • Liver Neoplasms
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Medulloblastoma
  • Wilms Tumor
  • Neuroblastoma
  • Osteosarcoma
  • Retinoblastoma
  • Rhabdomyosarcoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Neoplasms, Germ Cell and Embryonal
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Rhabdomyosarcoma, Embryonal
  • Sarcoma
  • Optic Nerve Glioma
  • Neoplasms
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral

Name

Location

Children's Oncology GroupArcadia, California  91006-3776