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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study of Paclitaxel and Ifosfamide Followed By Carboplatin and Etoposide With Stem Cell Support in Patients With Advanced Germ Cell Tumors With Unfavorable Prognostic Factors and Resistance to Cisplatin

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	14 and over	Other	MSKCC-93162 NCI-V94-0407, NCT00002558

Trial Description

Purpose:

Drugs used in chemotherapy, such as paclitaxel, ifosfamide, carboplatin, and etoposide work in different ways to stop the growth of tumor cells, either by killing them or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more tumor cells are killed.

This phase I trial is studying how well giving chemotherapy together with peripheral stem cell transplant works in treating patients with cisplatin -resistant advanced germ cell tumors.

Eligibility:

Eligibility criteria include the following:

• At least 14 years old
• No more than five previous courses of cisplatin
• At least 3 weeks since chemotherapy
• No previous high-dose chemotherapy with autologous bone marrow transplantation
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Bone marrow will be collected and preserved before beginning chemotherapy. Patients will receive a 24-hour continuous infusion of paclitaxel followed by infusions of ifosfamide once a day for 3 days. Patients will then receive injections of filgrastim twice a day until day 13. On days 11-13 peripheral stem cells will be collected. Treatment may be repeated every 2 weeks for two courses. Two weeks later, patients will receive infusions of carboplatin and etoposide for 3 days followed by injections of filgrastim until blood counts return to normal. Peripheral stem cells or bone marrow will be reinfused on day 5. Treatment will be repeated every 2 weeks for three courses. After treatment has been completed, some patients may undergo surgery.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Gnanamba Kondagunta, MD, Protocol chair		Ph: 646-422-4306; 800-525-2225

Registry Information
Official Title		Phase I Trial of Sequential Taxol/Ifosfamide and Dose-Intensive Carboplatin/Etoposide With Stem Cell Support in Cisplatin-Resistant Germ Cell Tumor Patients With Unfavorable Prognostic Features
Trial Start Date		1994-01-25
Trial Completion Date		2009-04-28
Registered in ClinicalTrials.gov		NCT00002558
Date Submitted to PDQ		1994-01-25
Information Last Verified		2007-03-08
NCI Grant/Contract Number		CA08748

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