Status and phase
Conditions
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About
Background:
Objectives:
Eligibility:
Design:
Full description
Background:
Primary Objectives:
Secondary Objectives:
Eligibility:
-Patients with histologically confirmed metastatic solid tumors and lymphomas; adequate organ function.
Study Design:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA:
Patients must have histologically-documented (confirmed at the Laboratory of Pathology, NCI), solid tumor malignancy, or Hodgkin's disease/non-Hodgkin lymphoma, that is metastatic or unresectable and for which standard curative measures do not exist or are associated with minimal patient survival benefit.
The Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Life expectancy >3 months.
Patients must have normal or adequate organ and marrow function as defined below:
Leukocytes greater than or equal to 3,000/mcL
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Total bilirubin less than or equal to 2.0 x institutional upper limit of normal (we will allow patients with Gilbert s syndrome with total bilirubin up to 2.5 mg/dL)
AST (SGOT)/ALT (SGPT) less than or equal to 3 x institutional upper limit of normal
---patients with metastatic disease in the liver less than or equal to 5 x ULN
Creatinine <1.5 x upper limit of normal
OR
Creatinine clearance
Age greater than or equal to 18
The effects of indenoisoquinolines on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after completion of indenoisoquinolines administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of indenoisoquinolines administration
Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
INCLUSION OF WOMEN AND MINORITIES:
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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