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Ifex (Ifosfamide) - Summary

 
 



WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY

Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. [see Warnings and Precautions (5.1-5.3)]

 

IFEX SUMMARY

IFEX (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide.

IFEX is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.


See all Ifex indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ifex (Ifosfamide)

Testicular Cancer
Source: MedicineNet Cancer Causes Specialty [2016.11.28]
Title: Testicular Cancer
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/28/2016 12:00:00 AM

Many Men Ignore Testicular Cancer Symptoms for Months
Source: MedicineNet Testicular Cancer Specialty [2016.07.06]
Title: Many Men Ignore Testicular Cancer Symptoms for Months
Category: Health News
Created: 7/5/2016 12:00:00 AM
Last Editorial Review: 7/6/2016 12:00:00 AM

IU study finds testicular cancer survivors may have hearing loss after cisplatin therapy
Source: Hearing / Deafness News From Medical News Today [2016.06.28]
Many testicular cancer survivors experience hearing loss after cisplatin-based chemotherapy, according to researchers at Indiana University.The researchers, led by Lois B. Travis, M.D., Sc.D.

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Published Studies Related to Ifex (Ifosfamide)

A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974). [2011.05]
CONCLUSION: This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC.

Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma. [2009.10]
Multidrug chemotherapy increases responses in advanced soft tissues sarcoma. Can a 20% increase of relative dose intensity of the MAID regimen, more improve responses? From 1994 to 1997, 162 patients were randomized in a phase III study to the conventional drug combination (6 cycles of MAID: 60, 7,500, 900 mg/m(2) for doxorubicin, ifosfamide and dacarbazine respectively), or at doses 20-33% higher per cycle (5 cycles of intensified MAID for similar cumulative doses) with systematic G-CSF...

Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. [2009.09.01]
PURPOSE: To evaluate the safety and efficacy of trabectedin in a phase II, open-label, multicenter, randomized study in adult patients with unresectable/metastatic liposarcoma or leiomyosarcoma after failure of prior conventional chemotherapy including anthracyclines and ifosfamide... CONCLUSION: Prior studies showed clinical benefit with trabectedin in patients with sarcomas after failure of standard chemotherapy. This trial documents superior disease control with the q3 weeks 24-hour trabectedin regimen in liposarcomas and leiomyosarcomas, although the qwk 3-hour regimen also demonstrated activity relative to historical comparisons. Trabectedin may now be considered an important new option to control advanced sarcomas in patients after failure of available standard-of-care therapies.

Randomized multicenter phase II trial of cisplatin and ifosfamide with or without paclitaxel in recurrent or metastatic carcinoma of the uterine cervix: a Hellenic Cooperative Oncology Group (HeCOG) study. [2009.08]
BACKGROUND: We undertook a randomized phase II trial to test whether the addition of paclitaxel (Taxol) to the cisplatin and ifosfamide (IP) combination could improve objective response (OR) rate, progression-free survival (PFS) and overall survival (OS) in patients with recurrent or metastatic cancer of the uterine cervix... CONCLUSION: The ITP combination merits further investigation in randomized phase III studies.

Chemotherapy: The role of ifosfamide and etoposide in Ewing sarcoma. [2009.05]
The EICESS-92 Trial compared the efficacy of cyclophosphamide and ifosfamide in patients with Ewing sarcoma. Subgroup analysis suggested that patients with large, localized tumors benefited from the addition of etoposide, whereas patients with metastases did not..

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Clinical Trials Related to Ifex (Ifosfamide)

Effect on QTc, Pharmacokinetics, Safety, and Preliminary Efficacy of Single-agent Palifosfamide-tris in Subjects With Advanced Solid Tumors [Active, not recruiting]
This is an open-label study of palifosfamide-tris administered intravenously on Days 1, 2, and 3 of a 21-day cycle to subjects with advanced solid tumors. Enrolled subjects will

receive a placebo-control infusion on Day - 1 and then commence palifosfamide-tris study

treatment 24 hours later on Day 1. Time-matched, intensive ECG monitoring will occur during and following placebo and

palifosfamide-tris infusions on Days - 1, 1, 2, 3 and 8. Generation of ECG data for study

analysis will be performed in a blinded fashion at a central ECG laboratory. Blood and urine sampling to characterize the pharmacokinetics of palifosfamide-tris will be performed on Days 1 through 8 of Cycle 1.

Brentuximab Vedotin, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma [Recruiting]
This phase I/II trial studies the side effects and best dose of brentuximab vedotin that can be combined with ifosfamide, carboplatin, and etoposide in treating patients with Hodgkin lymphoma that has come back (relapsed) or is not responding to treatment (refractory). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with an ifosfamide, carboplatin, and etoposide chemotherapy regimen may kill more cancer cells.

Fosaprepitant in Patients Receiving Ifosfamide-based Regimen [Active, not recruiting]
The goal of this clinical research study is to learn how different doses of fosaprepitant may effect how ifosfamide-based chemotherapy is absorbed by the body. Researchers also want to learn if fosaprepitant can help to control or prevent delayed nausea and/or vomiting that may be caused by chemotherapy. The safety of this drug will also be studied. Fosaprepitant is designed to block the natural substance in the brain that causes nausea and vomiting. This may help to prevent and/or control nausea and vomiting caused by chemotherapy.

Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors [Completed]
Primary Objectives:

- To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose

regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors.

- To evaluate the toxicity associated with the administration of Topotecan with

Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors. Secondary Objectives:

- To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT

50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA in children and young adults with solid tumors.

- To determine the median number of apheresis collections as well as the CD34/kg,

CD41/kg, CD61/kg and CD34: 41/kg and CD34: 61/kg per collection in patients electively undergoing concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3.

- To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo

expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent apheresis for PBMC collection in courses 2 or 3.

Ifosfamide With or Without O(6)-Benzylguanine in Treating Patients With Unresectable, Metastatic Solid Tumors [Terminated]
This randomized phase I trial is studying the side effects and best dose of O(6)-benzylguanine when given together with ifosfamide and to see how well it works compared to ifosfamide alone in treating patients with unresectable metastatic solid tumors. Drugs used in chemotherapy, such as ifosfamide and O(6)-benzylguanine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining ifosfamide with O(6)-benzylguanine may kill more tumor cells

more trials >>


Page last updated: 2016-11-28

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