Indenoisoquinoline LMP400 for Advanced Solid Tumors and Lymphomas

Completed · Phase 1

Conditions studied: Neoplasm, Lymphoma

In brief

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 see if this drug is a safe and effective treatment for solid tumors and lymphomas that have not responded to earlier treatment. Objectives: \- To see if Indenoisoquinoline LMP400 is a safe and effective treatment for advanced solid tumors or lymphomas. Eligibility: \- Individuals at least 18 years of age who have solid tumors or lymphomas that have not responded to treatment. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor samples may also be collected. The size and location of the tumors will be determined with imaging studies. * Indenoisoquinoline LMP400 is given in a 28-day cycle. Participants will receive the drug by intravenous infusion on days 1, 8, and 15 of each cycle, followed by a break of 13 days without the drug. * Treatment will be monitored with frequent blood tests and imaging studies. Tumor samples will be optional. * Participants will continue their cycles of treatment as long as the cancer does not grow and there are no severe side effects.

Key facts

Study ID

NCT01794104

Run by

National Cancer Institute (NCI)

People needed

21

Starts

2013-02-15

Expected to finish

2017-10-27

Last updated by the study team

2018-09-27

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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