Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Pharmacokinetics of Actinomycin D in Children With Cancer
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving
dactinomycin may help doctors learn how dactinomycin works in the body and how patients will
respond to treatment.
PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young
patients with cancer.
OBJECTIVES:
- Determine the pharmacokinetics (PKs) of dactinomycin in pediatric patients with cancer.
- Determine the degree of interpatient variation in the PKs of this drug.
- Determine the influence of characteristics such as age, tumor type, and concurrent
therapy on drug PKs in these patients.
- Correlate drug PKs with clinical response and toxicity observed in these patients,
focusing particularly on the incidence of severe liver toxicity or veno-occlusive
disease.
- Correlate pharmacogenetic variability with clinical and PK data.
OUTLINE: This is a multicenter study.
Patients undergo blood collection for pharmacokinetic sampling of dactinomycin at baseline
(prior to the initiation of dactinomycin) and periodically during course 1 of chemotherapy.
An additional blood sample is obtained before or after treatment for the collection of
peripheral blood lymphocytes. DNA from these cells is isolated and investigated for genetic
variation in genes relevant to the pharmacology of dactinomycin. Plasma concentrations of
dactinomycin are determined by liquid chromatography mass spectrometry analysis.
Patients are followed for 2 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
;
N/A
| 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 |
NCT00253474 -
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
|
Phase 1 | |
| Completed |
NCT00281944 -
Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
|
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 |
NCT00387920 -
Sunitinib in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT00459238 -
Telephone-Based Cancer Education With or Without Telephone-Based Counseling in Young Participants
|
N/A | |
| Completed |
NCT00138216 -
Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors
|
Phase 1 | |
| Terminated |
NCT00176540 -
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
|
N/A |