Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Phase I Study of AR-42 in Relapsed Myeloma, Chronic Lymphocytic Leukemia, and Lymphoma
| Verified date | May 2018 |
| Source | Ohio State University Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
RATIONALE: AR-42 may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of AR-42 in treating
patients with advanced or relapsed multiple myeloma, chronic lymphocytic leukemia, or
lymphoma.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | January 7, 2017 |
| Est. primary completion date | January 7, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Hematologic Malignances Arm - Patients must have CLL, prolymphocytic leukemia, or lymphoma (Hodgkins or Non-Hodgkins) as defined by 2008 WHO criteria or multiple myeloma as defined by IMWG criteria - Patients must have received at least one prior antineoplastic therapy, must have progressed after at least 1 prior therapy, and for whom no standard therapy is available or whom decline such options; prior autologous and/or allogeneic transplant is permitted - Prior biologic therapy or prior radiation is permitted; however, at least 28 days must have elapsed since the completion of prior therapy and patients must have recovered from all therapy-associated toxicities to no greater than grade 1 at the time of registration - Patients with symptomatic disease may receive palliative corticosteroids up to 1 week before initiating therapy - Patients must be off any prior chemotherapy for at least 28 days or 3 half lives, whichever is longer, and all therapy-related toxicity must have resolved to grade 1 or less - ANC >= 1000/uL - Total bilirubin < 1.5 mg/dL - Serum creatinine =< 1.5x institutional upper limit of normal or estimated creatinine clearance >= 50 ml/min by MDRD (original or abbreviated), or measured creatinine clearance >= 50 mL/min - ECOG/WHO performance score of 0-1 - Patients must be able to swallow capsules - Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial - Women with potential for child bearing must have a negative pregnancy test at screening; both men and women are required to use appropriate contraception during study - Platelet count >= 50,000/uL - AST and ALT =< 5x the institutional upper limit of normal Inclusion Solid Tumors Arm - Histologically or cytologically confirmed advanced or recurrent solid tumor malignancy. - Chemotherapy: up to three prior cytotoxic chemotherapy treatments. - Radiation Therapy: prior radiation therapy allowed. - Surgery: Prior curative and palliative intent surgery is allowed. - Age = 18 years - ECOG performance status 0-1 - Life expectancy of greater than 12 weeks. - Patients must have normal organ and marrow function as defined below: - Leukocytes = 3,000/mcL - Absolute neutrophil count = 1,500/mcL - Platelets = 100,000/mcL - Total bilirubin < 1.5 mg/dL - AST(SGOT)/ALT(SGPT) = 2.5 x institutional upper limit of normal (ULN); = 5 x ULN in presence of liver metastasis - Creatinine = 1.5 x ULN OR Creatinine clearance = 50 mL/min by MDRD (original or abbreviated), or measured creatinine clearance = 50 ml/min - Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial - Women with potential for child bearing must have a negative pregnancy test at screening; both men and women are required to use appropriate contraception during study Exclusion Hematologic Malignances Arm - Pregnant women are excluded from this study - Patients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drug - Breastfeeding should be discontinued if the mother is treated with AR-42 - Patients with malignant cells in the cerebrospinal fluid or parenchyma within the preceding 3 months or patients with primary CNS lymphoma are not eligible - Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) are not eligible - Patients receiving concurrent corticosteroids less than 1 week prior to protocol therapy other than for physiologic maintenance treatment or control of AIHA or ITP - Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug - Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation - Patients with a mean QTcB > 450 msec in males and > 470 msec in females - Patients who are receiving concurrent antineoplastic therapy - Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results - Patients with significant cardiovascular disease, including a myocardial infarction or unstable angina within 6 months or unstable cardiac arrhythmias are not eligible for the study - Known HIV infection Exclusion Solid Tumors Arm - Pregnant women are excluded from this study - Patients with malabsorption or any other condition that in the opinion of the principal investigator could cause difficulty in absorption of drug - Patients with malignant cells in the cerebrospinal fluid or parenchyma within the preceding 3 months or patients with primary CNS lymphoma are not eligible - Patients with uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) are not eligible - Patients receiving concurrent corticosteroids less than 1 week prior to protocol therapy other than for physiologic maintenance treatment or control of AIHA or ITP - Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug - Concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug - Patients with a "currently active" second malignancy that, in the opinion of the principal investigator, will interfere with patient participation, increase patient risk, shorten survival to < 1 year, or confound data interpretation. - Patients with a mean QTcB > 450 msec in males and > 470 msec in females - Patients who are receiving concurrent antineoplastic therapy. - Any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. - Patients with significant cardiovascular disease, including a myocardial infarction or unstable angina within 6 months or unstable cardiac arrhythmias are not eligible for the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The Ohio State University James Cancer Hospital | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Amir Mortazavi | Arno Therapeutics, National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events described using the NCI CTCAE criteria | Up to 3 years | ||
| Secondary | Clinical benefit | Up to 3 years | ||
| Secondary | Duration of response | Up to 3 years | ||
| Secondary | Time to progression | Up to 3 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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