Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00012194
Eligibility Criteria:
Inclusion Criteria:
* Advanced or metastatic, histologcally/cytologically confirmed malignant solid tumor, not expected to clinically benefit from standard therapy
* Life expectancy greater than 3 months
* Previous chemotherapy and/or radiotherapy must have been completed at least four weeks (six weeks for prior treatment with mitomycin or nitrosoureas) and patients should have recovered from all toxicities of that therapy before treatment under this protocol
* All patients must have recovered from any surgical procedure
* Serum creatinine must be within the institutional limits of normal and an estimated creatinine clearance of \>= 60 ml/min
* Normal bilirubin is required
* SGOT/AST must be less than or equal to 2.5 times the upper limit of institutional normal
* WBC \>= 4000/mm\^3
* Absolute neutrophil count \>= 2000/mm\^3
* Platelet count \>= 150,000/mm\^3
* Patients must have a Karnofsky Performance Status of 60% or greater
* Subjects who are fertile must use a medically acceptable contraceptive throughout the treatment period and for three months following cessation of treatment; subjects must be made aware, before entering this trial, of the risk in becoming pregnant or in fathering children
* A signed informed consent (approved by the IRB) must be obtained prior to trial entry
* Tumor site accessible for both pre-treatment and post-treatment biopsy is preferred during dose-finding, and is required for patients entering the expanded cohort at the MTD
* All patients require a central indwelling venous catheter prior to treatment under this protocol
Exclusion Criteria:
* Peripheral neuropathy \> grade I
* Any prior mediastinal radiotherapy
* Any history of coronary artery disease
* Class III or IV congestive heart failure according to the New York Heart Classification
* History of allergic reactions to appropriate diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered in conjunction with protocol directed chemotherapy
* Brain metastasis
* Uncontrolled intercurrent illness that would preclude tolerance and completion of the protocol treatment, including vigorous hydration prior and subsequent to cisplatin therapy
* Lactating or pregnant women are excluded to avoid potential harm to the unborn child or infant; documentation of a negative, serum beta-HCG pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
* Receipt of any investigational drug within 30 days before beginning treatment with study drug
* Medical, social, or psychological factors that would prevent the patient from completing the treatment protocol
* Patients with clinically significant hearing loss
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00012194
Study Brief:
Protocol Section:
NCT00012194