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		IUMC-830226 NCI-C83-0725

Objectives

I.  Determine the objective response rate and duration of remission of 
ifosfamide in patients with testicular cancer (and extra-gonadal or ovarian 
germ cell tumors, per Amendment 3, April 1985) refractory to cis-platinum 
combination chemotherapy.
II.  Determine the objective response rate and duration of remission of 
ifosfamide combination chemotherapy for "remission reinduction" in patients 
not cured with initial therapy.
III.  Determine the toxicity of ifosfamide in refractory testicular cancer 
(and extra-gonadal or ovarian germ cell tumors, per Amendment 3).
IV.  Determine the toxicity of ifosfamide in combination with cis-platinum 
with or without VP-16213, VP-16213 alone, or vinblastine with or without 
bleomycin in refractory testicular cancer (and extra-gonadal or ovarian germ 
cell tumors, per Amendment 3).

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 (or extra-gonadal or ovarian germ cell tumors, per Amendment 
3, April 1985) with clearly measurable and progressive disease who have failed 
previous chemotherapy with platinum, vinblastine, bleomycin and/or VP-16213.  
Patients progressing during treatment with cis-platinum combination 
chemotherapy are eligible.

Expected Enrollment

At least 25 evaluable patients will be entered on each regimen.  Per March 
1987 amendment, the primary regimens to be assessed are Regimens C and F.  In 
order to assess the effect of prior therapy on the response to salvage 
treatment, the following 3 subgroups of patients will be entered on each of 
these 2 regimens:  those treated with one prior therapy regimen who achieved a 
CR; those treated with one prior therapy regimen who did not achieve a CR; and 
those treated with more than one prior therapy regimen.  Forty patients will 
be accrued per group on each of the 2 regimens for a total of 240 patients.

Outline

Nonrandomized study.  Patients will enter Regimen A or one of the other 
regimens on the basis of prior experience with chemotherapy.  Regimen F was 
added per February 1985 amendment.  Per Amendment 2, March 1985, bladder 
protection with N-Acetylcysteine has been discontinued; patients will receive 
bladder protection with Mercaptoethane sulfonate, Mesna, NSC-113891.  Per 
March 1987 amendment, the major treatment regimens are Regimens C and F.
Regimen A:  Single-agent Chemotherapy.  Ifosfamide, IPP, NSC-109724; with 
N-Acetylcysteine, NAC, NSC-111180, for bladder protection.
Regimen B:  2-Drug Combination Chemotherapy.  IPP with NAC; cis-Platinum, 
CACP, NSC-119875.
Regimen C:  3-Drug Combination Chemotherapy.  IPP with NAC; CACP; VP-16213, 
VP-16, NSC-141540.
Regimen D:  2- or 3-Drug Combination Chemotherapy.  IPP with NAC; VP-16; with 
or without Bleomycin, BLEO, NSC-125066.
Regimen E:  2- or 3-Drug Combination Chemotherapy.  IPP with NAC; Vinblastine, 
VBL, NSC-49842; with or without BLEO.
Regimen F:  3-Drug Combination Chemotherapy.  IPP with NAC; CACP; VBL.

Munshi NC, Loehrer PJ, Williams SD, et al.: Comparision of N-acetylcysteine (NAC) and mesna as uroprotective agents in ifosfamide combination therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 8: A-506, 130, 1989.

Loehrer PJ Sr, Lauer R, Roth BJ, et al.: Salvage therapy in recurrent germ cell cancer: ifosfamide and cisplatin plus either vinblastine or etoposide. Ann Intern Med 109 (7): 540-6, 1988.[PUBMED Abstract]

Lauer RC, Roth B, Loehrer PJ, et al.: Cisplatin and ifosfamide and either VP-16 or vinblastine (VIP) as third line chemotherapy for metastatic testicular cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-389, 99, 1987.

Loehrer PJ, Einhorn LH, Williams SD: Salvage therapy for refractory germ cell tumor (RGCT) with VP-16 plus ifosfamide (IFX) plus cisplatin (DDP). [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-389, 100, 1985.

Trial Contact Information

Trial Lead Organizations

Indiana University Melvin and Bren Simon Cancer Center

Patrick Loehrer, MD, Protocol chair		Ph: 317-278-7418; 888-600-4822