Lymphoma Clinical Trial
Official title:
A Phase 0 Pharmacokinetic, Pharmacodynamic Study of ABT-888, an Inhibitor of Poly (ADP-ribose) Polymerase (PARP), in Refractory Solid Tumors and Lymphoid Malignancies
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | April 2009 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Kummar S, Kinders R, Gutierrez M, et al.: Inhibition of poly (ADP-ribose) polymerase (PARP) by ABT-888 in patients with advanced malignancies: results of a phase 0 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-3518, 2007.
Kummar S, Kinders R, Gutierrez ME, Rubinstein L, Parchment RE, Phillips LR, Ji J, Monks A, Low JA, Chen A, Murgo AJ, Collins J, Steinberg SM, Eliopoulos H, Giranda VL, Gordon G, Helman L, Wiltrout R, Tomaszewski JE, Doroshow JH. Phase 0 clinical trial of — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tumor poly (ADP-ribose) (PAR) levels from baseline to 3-6 hours after ABT-888 administration | No | ||
Primary | Pharmacokinetics | No | ||
Secondary | Safety of administering 1 dose of ABT-888 | Yes | ||
Secondary | Changes in PAR levels in peripheral blood mononuclear cells from baseline to after ABT-888 administration | No |
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