Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00012181

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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

  • Astrocytoma
  • Ependymoma
  • Glioma
  • Hodgkin Disease
  • Kidney Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Medulloblastoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Neuroblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Optic Nerve Glioma
  • Osteosarcoma
  • 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
  • Retinoblastoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Ewing
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Wilms Tumor
Clinical Trial Details
NCT number NCT00012181
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date April 2001
View Details
See also
  Status Clinical Trial Phase
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Completed NCT01164163 - INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Phase 1
Terminated NCT00949117 - Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer Phase 2
Completed NCT00985868 - AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors Phase 1
Completed NCT00281944 - Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors Phase 1
Completed NCT00253474 - PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma Phase 1
Recruiting NCT00084695 - Umbilical Cord Blood for Stem Cell Transplantation in Treating Young Patients With Malignant or Nonmalignant Diseases Phase 2
Completed NCT00053963 - FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia Phase 1
Completed NCT00003070 - Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Phase 3
Completed NCT00004212 - DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas Phase 1
Completed NCT00004005 - Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin Phase 2
Completed NCT00016861 - Irinotecan in Treating Children With Refractory or Progressive Solid Tumors Phase 1
Completed NCT00003754 - Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers Phase 2
Completed NCT00003173 - High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Phase 2
Recruiting NCT00898794 - Effect of Bevacizumab and VEGF on Platelet Clustering in Patients Who Are Receiving Bevacizumab for Cancer N/A
Terminated NCT00429702 - Diphenhydramine, Lorazepam, and Dexamethasone in Treating Nausea and Vomiting Caused By Chemotherapy Phase 2
Completed NCT00459238 - Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants N/A
Completed NCT00387920 - Sunitinib in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00138216 - Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors Phase 1
Completed NCT00070473 - Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors Phase 1