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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00003657
Eligibility Criteria:
Eligibility Criteria:
* Histologically documented malignancy
* Metastatic or locally unresectable malignancy
* Patient may be responding to therapy
* Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
* Relapsed germ cell carcinomas
* Relapsed lymphomas (ineligible for other BMT or SCT protocols
* SCLC in PR or CR
* Sarcomas in or near complete remission after induction chemotherapy
* Stage IIIB NSCLC responding to chemotherapy
* Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
* Other tumors without curative or first line therapy (not eligible for phase II or III studies)
* Aged 18 to 55 Physiologic years
\-- Performance status: PS 0-1
* Prior Treatment
* \> 1 week since surgery or RT
* \> 3 weeks since prior CT
* Informed Consent
* Required initial laboratory data:
* White Cell Count Life ≥ 3000/ul
* Platelet Count ≥ 100,000/ul
* Creatinine ≤ 1.5 x normal
* Bilirubin ≤ 1.5 x normal
* No current metastases
* BM Asp \& Bx
* Brain CAT
* Creatinine Clearance ≥ 60 cc/min
* SGOT \< 2.5 x normal
* No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia
* Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, or congestive heart failure
* Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulcer; until these conditions are corrected or controlled
* Pregnancy
* Unable to stop taking antihypertensive medication 24 hours prior to administration of Ethyol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00003657
Study Brief:
Protocol Section:
NCT00003657