Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00012181
First received: March 3, 2001
Last updated: May 3, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: alvocidib Other: pharmacological study |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 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:
MedlinePlus related topics:
Cancer
Hodgkin Disease
Kidney Cancer
Liver Cancer
Lymphoma
Neuroblastoma
Soft Tissue Sarcoma
Wilms' Tumor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
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 [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2001 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: alvocidib
Given IV
Other Names:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
|
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00012181 History of Changes |
| Other Study ID Numbers: | NCI-2012-01854, A0972, U01CA097452, CDR0000068491 |
| Study First Received: | March 3, 2001 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Astrocytoma Ependymoma Glioma Hodgkin Disease Kidney Neoplasms Liver Neoplasms Lymphoma 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 Neoplasms, Neuroepithelial Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Lymphoproliferative Disorders Lymphatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013