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

NCT00387608 | Completed Phase 1

• 4 other identifiers: 06017206-C-0172NCI-P6890CDR0000487701
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in tumor poly (ADP-ribose) (PAR) levels from baseline to 3-6 hours after ABT-888 administration

• Pharmacokinetics

Secondary Outcomes (2)

• Safety of administering 1 dose of ABT-888

• Changes in PAR levels in peripheral blood mononuclear cells from baseline to after ABT-888 administration

Interventions

veliparib DRUG

pharmacological study OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• 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 the poly (ADP-ribose) polymerase inhibitor ABT-888 in patients with advanced malignancies. J Clin Oncol. 2009 Jun 1;27(16):2705-11. doi: 10.1200/JCO.2008.19.7681. Epub 2009 Apr 13.

  PMID: 19364967 RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular

Interventions

veliparib; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shivaani Kummar, MD

  NCI - Medical Oncology Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: June 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)