MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring unspecified adult solid tumor, protocol specific, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, intraocular lymphoma, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III mycosis fungoides/Sezary syndrome, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV mycosis fungoides/Sezary syndrome, stage IV small lymphocytic lymphoma, Waldenstrom macroglobulinemia, primary central nervous system non-Hodgkin lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histological or cytological diagnosis of unresectable or metastatic solid-tumor cancer that is refractory to standard therapies OR for which no standard therapy exists
- Patients with refractory lymphoma (Hodgkin or non-Hodgkin) are also permitted to participate
Exclusion criteria:
- Active CNS metastases (primary brain tumors are permitted)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status ≥ 70%
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1.5 × 10^9/L
- Platelet count ≥ 100 × 10^9/L
- Total serum bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 2.5 × ULN (upper limit of normal for the clinical laboratory), but ≤ 5 × ULN is acceptable if due to hepatic metastases
- Serum albumin ≥ 2 g/dL
- Serum creatinine ≤ 2 mg/dL
- LVEF ≥ 50% on ECHO
- No significant abnormalities on the screening ECG (e.g., left bundle branch block, 3rd degree AV block, acute myocardial infarction or QTc interval > 450 msec)
- No history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome)
- Able to swallow MP470 capsules
- Capable of fasting for 6 hours
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months following completion of study treatment
Exclusion criteria:
- Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of oral MP470, or put the study outcomes at risk
- Any serious, uncontrolled active infection that requires systemic treatment
- History of significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, and/or myocardial infarction
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- Recuperated from any prior surgical procedures including at least 4 weeks rest since a major surgery
Exclusion criteria:
- Patient has received any anticancer agent(s) within the past 3 weeks, including investigational agents, chemotherapy (6 weeks for nitrosoureas or mitomycin), immunotherapy, biologic, or hormonal therapy other than luteinizing hormone-releasing hormone (LHRH) agonists
- Patient has received radiation therapy within the past 4 weeks
- Patient has a grade 2 or more severe toxicity (other than alopecia) continuing from prior anticancer therapy
- Patient requires treatment with immunosuppressive agents other than corticosteroids that have been at stable doses for at least 2 weeks
Sites / Locations
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
- South Texas Accelerated Research Therapeutics