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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care, Treatment Closed 18 and over MSKCC-89022 NCI-V89-0109

Objectives

I.  Evaluate the toxicity of cisplatin/cyclophosphamide when administered with 
diethyldithiocarbamate (DDTC) in patients with advanced malignancies.
II.  Examine further the toxicity of DDTC when administered as a protective 
agent against cisplatin-induced toxicity.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients at least 18 years of age 
with histologically confirmed advanced malignancies for which a regimen of 
cisplatin and cyclophosphamide, as provided in this protocol, is appropriate 
and for whom no other option offering a greater chance of success (cure, 
prolongation of life, palliation of symptoms) exists; patients with ovarian 
cancer must have undergone appropriate surgical assessment for staging and 
debulking prior to entry.  No prior chemotherapy is allowed, and at least 1 
year must have elapsed since any prior radiotherapy.  Concomitant phenytoin, 
isoniazid, or coumarin is not permitted.  Patients must be able to refrain 
from alcohol intake for at least 72 hours prior to and after 
diethyldithiocarbamate (DDTC) treatment, and they must be able to tolerate the 
fluid load (hydration) required by this trial.  Clinically normal hearing is 
required, as are the following laboratory parameters:  WBC at least 3,500 and 
platelets at least 120,000; serum bilirubin no more than 2.0 mg/dl; and serum 
creatinine no more than 1.5 mg/dl, serum BUN no more than 30 mg/dl, and 
creatinine clearance at least 60 ml/minute.  The following conditions exclude: 
 diabetes mellitus, a requirement for hypoglycemic agents, severe 
chronic-obstructive pulmonary disease, and constrictive arterial disease.  
Patients with a serious psychiatric history or who, in the opinion of the 
investigator, will not be able to tolerate the acute, self-limited anxiety 
associated with DDTC administration are ineligible.

Expected Enrollment

A maximum of 15 patients will be entered; accrual will cease after either 5 or 
10 patients have been entered if it is clear at that time that toxicity is the 
same as that anticipated with CDDP/CTX alone.

Outline

Nonrandomized study.
2-Drug Combination Chemotherapy followed by Toxicity Attenuation.  
Cyclophosphamide, CTX, NSC-26271; Cisplatin, CDDP, NSC-119875; followed by 
Diethyldithiocarbamate, DDTC, NSC-38583.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Maurie Markman, MD, Protocol chair(Contact information may not be current)		Ph: 216-445-6888; 800-862-7798