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:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT00045006
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Histologically confirmed advanced primary or metastatic solid tumor, including, but not limited to, the following:
* Androgen-independent prostate cancer
* Breast cancer
* Ovarian cancer
* Head and neck cancer
* Non-small cell lung cancer
* Bladder cancer
* Kidney cancer
* Diagnosis of lymphoma, multiple myeloma, leukemia, or myelodysplastic syndromes (MDS), including, but not limited to, the following:
* Intermediate-grade or follicular non-Hodgkin's lymphoma
* Hodgkin's lymphoma
* Patients with lymphoma or multiple myeloma must be ineligible for peripheral blood stem cell transplantation
* For patients with solid tumors (except prostate cancer):
* Disease progression based on development of new lesions or an increase in pre-existing lesions
* Biochemical marker increase must not be sole criterion for disease progression
* For prostate cancer patients only:
* Disease progression based on rising prostate-specific antigen (PSA) values, transaxial imaging, or radionuclide scans
* Increase in disease-related symptoms must not be sole manifestation of progression
* Patients receiving an antiandrogen as part of first-line hormonal therapy must show disease progression off of the antiandrogen prior to study
* Biochemical progression (at least 25% increase over range of values) defined as 1 of the following:
* Rising PSA documented by at least 3 consecutive measurements obtained at least 1 week apart
* Rising PSA documented by at least 2 consecutive measurements obtained more than 1 month apart
* PSA at least 4 ng/mL
* Testosterone no greater than 50 ng/mL
* If no prior orchiectomy, must maintain castrate levels of testosterone
* Disease must be refractory to standard therapy or for which no curative therapy exists
* No active CNS or epidural tumors
* Hormone receptor status:
* Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3 (patients with solid tumors)
* Platelet count greater than 25,000/mm\^3 (patients with hematologic malignancy)
* Absolute neutrophil count at least 500/mm\^3 (patients with hematologic malignancy)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN
* PT no greater than 15 seconds
Renal
* Creatinine no greater than 2.0 mg/dL
Cardiovascular
* No New York Heart Association class III or IV heart disease
Pulmonary
* No severe debilitating pulmonary disease
Other
* No infection requiring IV antibiotics
* No other severe medical problems that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* At least 4 weeks since prior chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 4 weeks since prior ketoconazole
* At least 2 weeks since prior steroids for patients with lymphoma
* Concurrent gonadotropin-releasing hormone analogs or diethylstilbestrol to maintain castrate levels of testosterone allowed for prostate cancer patients
* No concurrent ketoconazole
Radiotherapy
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy to sole measurable lesion
Surgery
* See Disease Characteristics
* No concurrent surgery
Other
* Recovered from all prior therapy
* At least 4 weeks since prior palliative therapy for solid tumor patients with progressive metastatic disease (if present)
* At least 4 weeks since prior investigational anticancer therapeutic drugs
* At least 2 weeks since prior conventional cytotoxic therapy for patients with leukemia or MDS
* At least 4 weeks since prior investigational therapy for patients with leukemia or MDS
* No other concurrent investigational drugs
* No other concurrent anticancer agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00045006
Study Brief:
Protocol Section:
NCT00045006