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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT00003512
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
* Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
* Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination)
* Biochemical evidence of Waldenstrom's macroglobulinemia
* Abnormal proteins in serum and urine
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2000/mm3
* Platelet count at least 50,000/mm3
Hepatic:
* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No serious lung disease, such as chronic obstructive pulmonary disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study
* No active infection
* No non-malignant systemic disease
* Not a high medical or psychiatric risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agent
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy
* No concurrent antineoplastic agents
Endocrine therapy:
* See Disease Characteristics
* Concurrent corticosteroids allowed
Radiotherapy:
* See Disease Characteristics
* At least 8 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
* Recovered from prior surgery
Other:
* No prior antineoplastons
* Prior cytodifferentiating agents allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00003512
Study Brief:
Protocol Section:
NCT00003512