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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT00183820
Eligibility Criteria:
Inclusion Criteria:
1. Prior histologic or serologic confirmation of testicular or extragonadal germ cell neoplasm not amenable to surgical cure
2. Must have refractory germ cell neoplasm defined as one or more of the following:
* patients who progress during or within 4 weeks of cisplatin-containing tx, OR - patients who have failed initial salvage chemotx regimens, including high-dose tx (chemotx with stem cell support), POMB-ACE tx, VeIP, or VIP
3. Must have one or more of the following (check all that apply):
* unidimensionally measurable doze assessed within 14 days prior to registration,
* elevated β-HCG \> 20 mIU assessed within 24-48 hours prior to registration, OR
* AFP \> 2 x uln assessed within 5-7 days prior to registration
Note: Soft tissue dz, which has been radiated in the 2 months prior to registration, is not assessable as measurable dz.
4. X-rays, scans, or PE for non-measurable dz must have been completed within 14 days of registration
5. May have received prior surgery or RT. At least 3 weeks must have elapsed since completion of previous tx and must have recovered from any adverse effects
6. Zubrod PS less than or equal to 2
7. Greater than or equal to 16 years of age
8. AGC greater than or equal to 1.5; platelets greater than or equal to 100,000
9. Total bilirubin \< 2.5 x uln; SGOT and alk phos \< 5 x uln (obtained within 14 days prior to registration)
10. LDH (obtained within 7 days prior to registration)
11. Creatinine \< 2.5 x uln or calc or meas CrCl greater than or equal to 40 ml/min (obtained within 14 days prior to registration; patient must not be on renal dialysis)
12. Serum K+ and Mg++ within inst range of normal (obtained within 14 days prior to registration)
13. Men of reproductive potential must agree to use effective contraceptive method
14. Signed informed consent (including HIPAA authorization)
Exclusion Criteria:
1. Prior tx with cytotoxic or experimental agents within 14 days prior to registration
2. Evidence of concurrent infection (T \> 96.8F but \< 101.5F; WBC \< 11.0 unless these values can be ascribed to another tumor-related phenomena)
3. Other prior malignancy, except adequately treated basal cell or squamous cell skin cancer, adequately treated stage I or II cancer from which patient is currently in chemoradiation (CR), or any other cancer from which patient has been disease-free for 5 years
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Study:
NCT00183820
Study Brief:
Protocol Section:
NCT00183820