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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00003993
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists
* Prostate cancer patients must have the following:
* Tumor progression following blockade of both testicular and adrenal androgens
* Serum testosterone in the castrate range (less than 20 ng/mL)
* At least 3 months since prior suramin therapy
* At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment
* Luprolide should continue if no prior orchiectomy
* No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0 or 1
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,500/mm\^3 OR
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 8 g/dL
Hepatic:
* Hepatitis B surface antigen negative
* PT no greater than 14 seconds
* PTT no greater than 35 seconds
* Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease
* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* Albumin at least 2.5 g/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
* Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL
Cardiovascular:
* No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment
* No evidence of CAD on EKG
Pulmonary:
* FEV1-1 at least 70% predicted
* DLCO at least 60% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* At least 1 week since active infection requiring antibiotics
* No other medical or psychiatric condition that would preclude study
* No prior or concurrent seizure disorders controlled with medication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior interleukin-2
* At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior bryostatin 1
* At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas
* No absolute requirement for corticosteroids
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy for solid tumors or lymphomas
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior surgery for solid tumors or lymphomas
Other:
* No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003993
Study Brief:
Protocol Section:
NCT00003993