Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors

Overview

About this study

This phase I trial studies the side effects and best dose of veliparib when given together with liposomal irinotecan in treating patients with solid tumors. Liposomal irinotecan and veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients must have pathologically confirmed diagnosis of a solid tumor cancer for which there is no known standard therapy capable of extending life expectancy.
  • Prior poly ADP ribose polymerase (PARP) inhibitor therapy is allowed; patients with ovarian cancer and a BRCA mutation should have had prior treatment with olaparib per guidelines for standard of care treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
  • Hemoglobin > 9 g/dL.
  • Leukocytes ≥ 3,000/mcL.
  • Absolute neutrophil count ≥ 1,500/mcL without the use of hematopoietic growth factors.
  • Platelets ≥ 100,000/mcL.
  • Total bilirubin below normal institutional upper limit of normal (ULN).
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal (≤ 5 x upper limit of normal [ULN] is acceptable if liver metastases are present).
  • Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Women of childbearing potential and male patients should use effective contraception during treatment with MM-398 and for 90 days following the final dose of veliparib and MM-398 for both female and male patients; 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.
  • Ability to understand and the willingness to sign a written informed consent document.
  • IMAGING CORRELATIVE STUDY: Patients will be eligible to participate in the FMX imaging study if they do not meet any of the following criteria:
    • Evidence of iron overload as determined by:
      • Fasting transferrin saturation of > 45%; and/or
      • Serum ferritin levels > 1000 ng/ml.
    • A history of allergic reactions to any of the following:
      • Compounds similar to ferumoxytol or any of its components as described in full prescribing information for ferumoxytol injection;
      • Any IV iron replacement product (e.g., parenteral iron, dextran, iron-dextran, or parenteral iron polysaccharide preparations);
      • Multiple drugs.
    • Unable to undergo MRI or for whom MRI is otherwise contraindicated (e.g., presence of errant metal, cardiac pacemakers, pain pumps or other MRI incompatible devices; or history claustrophobia or anxiety related to undergoing MRI).

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients must have completed prior biological therapies and/or targeted therapies ≥ 2 weeks prior to study enrollment; patients who have had radiation to the pelvis or other bone marrow-bearing sites will be considered on a case by case basis and may be excluded if the bone marrow reserve is not considered adequate (i.e., radiation to > 25% of bone marrow).
  • Patients who are receiving any other investigational agents.
  • Subjects with symptomatic brain metastases will be excluded from trial secondary to poor prognosis; however, subjects who have had treatment for their brain metastasis and whose brain disease is stable without steroid therapy for at least 3 months may be enrolled.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib and MM-398; if patients have a history of allergic reactions to compounds resembling MM-398, they will be excluded from participating in the FMX MRI study, if applicable.
  • Patients who have severe hypersensitivity to irinotecan hydrochloride (HCl).
  • Patients with known and confirmed diagnosis of interstitial lung disease (ILD).
  • Clinically significant gastrointestinal (GI) disorders, including history of small bowel obstruction unless the obstruction was a surgically treated remote episode.
  • Patient is unable to swallow or keep down oral medication.
  • Patients at the National Cancer Institute (NCI) site and other selected centers who are willing to undergo an optional pre-treatment ferumoxytol MRI must not have evidence of iron overload, a known hypersensitivity to ferumoxytol or any other IV iron product, a documented history of multiple drug allergies, or those for whom MRI is otherwise contraindicated, including claustrophobia or anxiety related to undergoing MRI; this exclusion criterion applies only to patients enrolling at NCI and other selected sites; of note, the principal investigator (PI) will allow other centers to offer FMX MRI scans if the site in question is willing and the site PI can identify the necessary resources and expertise at their center.
  • Active infection.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with any of these agents.
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Patients who need chronic use of medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible.
  • Patients with a high risk of seizures should be excluded from the protocol (e.g., those patients with an uncontrolled seizure disorder, and/or patients who have had a focal or generalized seizure within the last 12 months).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ciara O'Sullivan, M.B., B.Ch.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Ciara O'Sullivan, M.B., B.Ch.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Ciara O'Sullivan, M.B., B.Ch.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20366130

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