Ifex (Ifosfamide / Mesna) - Summary

IFEX SUMMARY

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

IFEX, used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should ordinarily be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.

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NEWS HIGHLIGHTS

Media Articles Related to Ifex (Ifosfamide / Mesna)

Testicular Cancer Survivors Face Other Ills
Source: MedicineNet Testicular Cancer Specialty [2009.10.29]
Title: Testicular Cancer Survivors Face Other Ills
Category: Health News
Created: 10/28/2009 4:10:00 PM
Last Editorial Review: 10/29/2009

Testicular Cancer Survivors Face Other Ills (HealthDay)
Source: Y! Health News Search RSS Feed [2009.10.28]
HealthDay - WEDNESDAY, Oct. 28 (HealthDay News) -- For men with testicular cancer, survival comes at a price: New research suggests that those who recover from the disease face higher risks of long-term illness unrelated to tumors.

Researchers Spot Genes Linked to Testicular Cancer
Source: MedicineNet Testicular Cancer Specialty [2009.06.02]
Title: Researchers Spot Genes Linked to Testicular Cancer
Category: Health News
Created: 6/2/2009 7:00:00 AM
Last Editorial Review: 6/2/2009

Male Infertility Tied to Testicular Cancer Risk
Source: MedicineNet Testicular Cancer Specialty [2009.02.24]
Title: Male Infertility Tied to Testicular Cancer Risk
Category: Health News
Created: 2/24/2009 2:00:00 AM
Last Editorial Review: 2/24/2009

Marijuana Linked to Aggressive Testicular Cancer
Source: MedicineNet Testicular Cancer Specialty [2009.02.10]
Title: Marijuana Linked to Aggressive Testicular Cancer
Category: Health News
Created: 2/10/2009 2:00:00 AM
Last Editorial Review: 2/10/2009

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Published Studies Related to Ifex (Ifosfamide / Mesna)

Comparative pharmacokinetics of oral and intravenous ifosfamide/mesna/methylene blue therapy. [1998.09]
Oral treatment with ifosfamide results in dose-limiting encephalopathy... From the data, we conclude that methylene blue has a neuroprotective effect and that the pharmacokinetics of ifosfamide are not influenced by its comedication.

Oral ifosfamide/mesna versus intravenous ifosfamide/mesna in non-small-cell lung cancer: a randomized phase II trial of the EORTC lung cancer cooperative group. [1996.08]
BACKGROUND: Chronic oral administration of anticancer drugs may offer therapeutic advantages... CONCLUSIONS: Both arms have some activity in non-small-cell lung cancer; while OSI was less myelosuppressive than IVI, it was associated with a higher incidence of CNS toxicity. Oral administration of ifosfamide, in the schedule and daily dose tested here cannot be recommended.

Phase II evaluation of ifosfamide/mesna in metastatic prostate cancer. A Southwest Oncology Group study. [1996.08]
The combination of ifosfamide and mesna was evaluated in a phase II trial in the treatment of metastatic prostate cancer. Two separate groups of patients were to be evaluated: patients with no prior hormonal therapy and hormonally refractory patients... These drugs do not warrant further evaluation in the disease.

A randomized phase II study of ifosfamide/mesna/cisplatin plus G-CSF or etoposide/cisplatin plus G-CSF in advanced non-small cell lung cancer: a Cancer and Leukemia Group B study. [1996.06]
This Phase II study was designed to determine the efficacy of two chemotherapy regimens with G-CSF support for patients with advanced non-small cell lung cancer (NSCLC). One-hundred and one patients with Stage IIIB or IV NSCLC and performance status 0-1 were randomized to receive ifosfamide 2.0 g/m2 days 1-3, mesna 400 mg/m2 at 0, 4, 6 h days 1-3, cisplatin 33 mg/m2 days 1-3 or etoposide 200 mg/m2 days 1-3, cisplatin 35 mg/m2 days 1-3...

A pilot study of cisplatin, ifosfamide and mesna in the treatment of malignant mixed mesodermal tumors of the ovary. [2007.05]
PURPOSE: To evaluate the efficacy and toxicity of cisplatin and ifosfamide in the treatment of patients with malignant mixed mesodermal tumor (MMMT) of the ovary... CONCLUSION: The combination of cisplatin and ifosfamide/mesna demonstrated activity against MMMT of the ovary. Response durations were short, however, and the regimen was associated with significant toxicity. Novel agents with activity against MMMT of the ovary and acceptable toxicity are needed.

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Clinical Trials Related to Ifex (Ifosfamide / Mesna)

Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors [Completed]
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors.

PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.

Ifosfamide With or Without Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cancer of the Uterus [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide alone is more effective than ifosfamide plus paclitaxel in treating patients with cancer of the uterus.

PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with or without paclitaxel in treating patients with advanced, refractory, or recurrent cancer of the uterus.

Ifosfamide With or Without O(6)-Benzylguanine in Treating Patients With Unresectable, Metastatic Solid Tumors [Completed]
RATIONALE: 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.

PURPOSE: 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.

A Scandinavian Sarcoma Group Protocol for Patients With High-Risk Soft Tissue Sarcoma of the Extremities and Trunk Wall [Recruiting]
SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk tumors. SSG XX will evaluate chemo- and radiotherapy given adjuvantly to these patients. In a specified group of patients also preoperatively given therapy will be studied.

Paclitaxel, Ifosfamide, and Carboplatin Followed By Autologous Stem Cell Transplant in Treating Patients With Germ Cell Tumors That Did Not Respond to Cisplatin [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, ifosfamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. An autologous peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed.

PURPOSE: This phase I/II trial is studying the side effects and best dose of ifosfamide when given together with paclitaxel and carboplatin followed by an autologous stem cell transplant and to see how well they work in treating patients with germ cell tumors that did not respond to cisplatin.

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