Status:
COMPLETED
Indenoisoquinoline LMP400 for Advanced Solid Tumors and Lymphomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neoplasm
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
Background: \- Indenoisoquinoline LMP400 is an experimental cancer treatment drug. It damages DNA in tumor cells. Tumor cells with damaged DNA may die, resulting in cell death. Researchers want to se...
Detailed Description
Background: * Indenoisoquinolines are non-camptothecin topoisomerase (Top1) inhibitors that form stable DNA-Top1 cleavage-complexes, have a preference for unique DNA cleavage sites, and are active ag...
Eligibility Criteria
Inclusion
- 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
- greater than or equal to 60 mL/minute for patients with creatinine levels
- greater than or equal to 1.5 x institutional upper limit of normal
- 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:
- Patients must have recovered to at least eligibility levels due to adverse events (AEs) and/or toxicity of prior chemotherapy or biologic therapy. They must not have had major surgery, chemotherapy, radiotherapy, or biologic therapy within 3 weeks (6 weeks for nitrosoureas and mitomycin C, or 2 months for UCN-01). Patients must be greater than or equal to2 weeks since any investigational agent administered as part of a Phase 0 study (also referred to as an early Phase I study or pre-Phase I study where a subtherapeutic dose of drug is administered) at the PI s discretion, and should have recovered to eligibility levels from any toxicities. However, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy. Prior therapy with topoisomerase I inhibitors is allowed.
- Patients who are receiving any other investigational agents.
- Patients with known active brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with brain metastasis stable for at least 4 weeks following surgery and/or radiation are eligible.
- Uncontrolled incurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with LMP400. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
- INCLUSION OF WOMEN AND MINORITIES:
- \- Both men and women of all races and ethnic groups are eligible for this trial.
Exclusion
Key Trial Info
Start Date :
February 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01794104
Start Date
February 15 2013
End Date
October 27 2017
Last Update
September 27 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892