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
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT00003754 -
Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers
|
Phase 2 | |
Completed |
NCT00016861 -
Irinotecan in Treating Children With Refractory or Progressive Solid Tumors
|
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 |
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 |