Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
The Use of Supplemental Oral Glutamine (GLN) to Decrease Morbidity in Patients Undergoing Stem Cell Transplantation: A Pediatric Blood and Marrow Transplant Consortium Study
RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system
in children who are undergoing stem cell transplantation.
PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in
reducing inflammation of the mouth and digestive system in children who are undergoing
peripheral stem cell transplantation.
OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the
severity and duration of mucositis in children undergoing stem cell transplantation. II.
Determine the safety of this regimen in these patients. III. Determine serum glutamine
levels achieved during this regimen in these patients.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified
according to inclusion of total body irradiation in the conditioning regimen (yes vs no).
Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on
the day of admission for the stem cell transplant and continuing for 28 days or until
hospital discharge, whichever is first.
PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study
within 2 years.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| 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 |
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 |