Neoplasm Clinical Trial
Official title:
A Phase I/IIa Safety and Efficacy Study of Topical Phenylephrine Applied to Oral Mucosa in Bone Marrow Transplant Patients Receiving Cytoxan Plus Total Body Irradiation
This phase I/II trial studies the safety of topical phenylephrine solution and to see how well it works in preventing oral mucosa (mouth sores) in bone marrow transplant patients receiving cyclophosphamide and total body radiation therapy. Topical phenylephrine solution may prevent or lessen the severity of oral mucosa in patients receiving cyclophosphamide and total body radiation prior to undergoing a bone marrow transplant.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of phenylephrine (topical phenylephrine solution)
applied topically to the oral mucosa of bone marrow transplant patients treated with
cyclophosphamide plus total body irradiation.
II. To determine the maximum tolerated dose (MTD) and recommended phase II dose of
phenylephrine applied topically to the oral mucosa of bone marrow transplant patients treated
with cyclophosphamide plus total body irradiation.
III. To evaluate the efficacy of phenylephrine applied topically to the oral mucosa in
preventing and/or decreasing severity of oral mucositis in bone marrow transplant patients
treated with cyclophosphamide plus total body irradiation.
OUTLINE: This is a phase I, dose-escalation study of topical phenylephrine solution followed
by a phase II study.
Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical
phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each
cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide
infusion, and 15-20 minutes prior to each radiation treatment.
After completion of study treatment, patients are followed up weekly for 2 weeks and then at
3 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT00199836 -
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.
|
Phase 1 | |
| Completed |
NCT01672944 -
Evaluating Biobanking Educational Tools
|
N/A | |
| Not yet recruiting |
NCT02226289 -
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
|
Phase 2 | |
| Completed |
NCT02747342 -
A Phase 1 Trial of SHR3680 With or Without SHR3162 in Prostate Cancer
|
Phase 1 | |
| Completed |
NCT02759640 -
A Phase I Trial of HS-10241 in Solid Tumors
|
Phase 1 | |
| Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
| Completed |
NCT02536586 -
A Study of LY3023414 in Japanese Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02309164 -
The Use of Acupuncture for Treatment of Chemotherapy-induced Peripheral Neuropathy (CIPN).
|
N/A | |
| Completed |
NCT02394821 -
Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
|
Phase 3 | |
| Completed |
NCT01457196 -
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions
|
N/A | |
| Completed |
NCT00143533 -
Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05450562 -
Dose Escalation and Expansion Study of SAR444200-based Regimen in Adult Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00001835 -
Oxaliplatin in Cancer Patients With Impaired Kidney Function
|
Phase 1 | |
| Completed |
NCT00001341 -
A Phase I Trial of ZD1694 (TOMUDEX), an Inhibitor of Thymidylate Synthase, in Pediatric Patients With Advanced Neoplastic Disease
|
Phase 1 | |
| Completed |
NCT01425008 -
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
|
Phase 1 | |
| Recruiting |
NCT05101798 -
The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial
|
Phase 2 | |
| Completed |
NCT01920061 -
A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)
|
Phase 1 | |
| Terminated |
NCT03251924 -
A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT02851706 -
Natural History of and Specimen Banking for People With Tumors of the Central Nervous System
|