ABT-888 in Patients With Refractory Solid Tumors or Hematologic Cancer

This is an interventional treatment trial for Leukemia focused on measuring unspecified adult solid tumor, protocol specific, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma Read More

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy, meeting 1 of the following criteria:

  • Solid tumor that is refractory to ≥ 1 line of standard treatment OR for which no standard therapy is available

    • Must have ≥ 1 lesion amenable to percutaneous biopsy (for solid tumor patients enrolled after the initial phase of the study)
  • Chronic lymphocytic leukemia (CLL) or follicular lymphoma with no current indication for standard therapy OR disease that has failed ≥ 1 line of standard therapy
• No disease-associated symptoms requiring immediate therapy or other interventions
• Must be willing to undergo tumor biopsies* after the initial phase of the study NOTE: *Patients with CLL undergo peripheral blood collection instead of biopsy
• No primary brain tumors, brain metastases, or leptomeningeal disease

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy ≥ 3 months
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL
• Bilirubin < 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• INR ≤ 1.4
• PTT ≤ 36 seconds
• Calcium (corrected) normal
• Magnesium < 1.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study completion
• No history of seizures
• No evidence of bleeding diathesis

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmias
• No psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

• At least 2 weeks since prior radiation therapy or surgery and recovered
• At least 2 weeks since other prior therapy and recovered
• No concurrent antiretroviral therapy for HIV-positive patients
• No concurrent lung, liver, or mediastinal lymph node biopsies
• No other concurrent investigational agents