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| 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 |
| Study Start Date: | April 2001 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed relapsed or refractory solid tumor or lymphoma including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 51 Study Locations| Study Chair: | James A. Whitlock, MD | Vanderbilt Children's Hospital |
More Information
| 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 |
|
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 |
|
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 |
|
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 |