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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00002558
Eligibility Criteria:
Inclusion criteria:
* Male/Female with histologically confirmed GCT with review by the Department of Pathology at this center.
* Patients with advanced GCT, including patients with:
measurable or evaluable disease,
* patients with only elevated serum tumor markers (AFP and/or HCG), or
* patients with known residual disease after postchemotherapy surgery. Eligible patients must have established clinical resistance to cisplatin by their failure to achieve a durable CR to a cisplatin-based regimen.
* Prior treatment limited to ≤ 6 prior cycles (≤ four cycles preferred) of cisplatin. (GROUP A)
* Prior therapy \> 6 cycles of cisplatin. (GROUP B)
* Therapy must have been discontinued at least 3 weeks before entry onto protocol.
* Patients must have one or more unfavorable prognostic factors for achieving a CR to cisplatin-based salvage therapy. These are:
* Extragonadal primary site.
* Testis/ovarian primary site with the best response of an IR to first-line therapy, or a partial response with normal tumor markers of six months or less in duration.
* Prior treatment with ifosfamide-containing therapy
* General medical condition sufficient to allow for general anesthesia at the time of pheresis catheter placement.
* Patients must have negative serology for Human Immunodeficiency Virus.
* Laboratory criteria for protocol entry:
WBC ≥ 3000/ul Platelets 3 100,000/ul Cr Clearance \> 50 cc/min\*
\* (unless renal dysfunction is due to tumor obstructing the ureters in which case eligibility will be determined by the Principal Investigator).
* Age ≥ 15 years.
* Signed informed consent.
Exclusion Criteria:
* Presence of active infection
* Concurrent treatment with chemotherapy or
* Inability to comply with the treatment protocol or to undergo the specified follow-up tests for safety or effectiveness.
* Prior high-dose therapy with AuBMT.
* Patients must have recovered from recent surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00002558
Study Brief:
Protocol Section:
NCT00002558