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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about the ways a patient's body handles the drug.

PURPOSE: This early phase I trial is studying the side effects and best dose of ABT-888 in patients with refractory solid tumors or hematologic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Poly(ADP-ribose) Polymerase Inhibitors; Veliparib

Criteria

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