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Pilot Phase II Chemotherapy with IPP plus N-Acetylcysteine for Refractory Testicular Cancer

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed no age specified NCI-D82-067-825

Objectives

I.  Determine the objective response and duration of response in patients with 
testicular cancer refractory to cis-platinum combinations who are treated with 
ifosfamide, with N-acetylcysteine for bladder protection.
II.  Determine the toxicity of high-dose ifosfamide in patients with 
refractory testicular cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with a tissue diagnosis of 
testicular cancer who have clearly measurable and progressive disease.  
Patients must have previously been treated with cis-platinum, vinblastine, 
bleomycin, and VP-16 and must be clearly refractory to these agents.  The 
serum creatinine may not be greater than 3.0 mg/dl, and the creatinine 
clearance must be at least 50 mg/ml.

Expected Enrollment

Protocol closed February 1984.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Ifosfamide, IPP, NSC-109724; plus N-Acetylcysteine 
for bladder protection.

Published Results

Wheeler BM, Loehrer PJ, Williams SD, et al.: Ifosfamide in refractory male germ cell tumors. J Clin Oncol 4 (1): 28-34, 1986.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Indiana University Melvin and Bren Simon Cancer Center

Lawrence Einhorn, MD, Protocol chair
Ph: 317-274-3515; 888-600-4822

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.