• Return to search results
• Start new search

Investigator(s):
Shivaani Kummar, M.D. Principal Investigator Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov	Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov

---

Primary Eligibility:

• Histologically confirmed solid tumor or lymphoid (e.g., lymphoma or chronic lymphocytic leukemia) malignancies
  • Refractory to standard therapy or no acceptable standard treatment options exists
    • Patients with lymphoid malignancies must have disease progression after standard therapy AND have either refused stem cell transplantation (SCT) or SCT is not indicated
• No gliomas, symptomatic CNS metastases, or carcinomatous meningitis
  • Patients with a history of CNS metastases are eligible, at the discretion of the principal investigator, provided they have received treatment and their CNS metastatic disease status has remained stable for ≥ 3 months without requiring steroids or anti-seizure medications
• Recovered from prior therapy
• Prior ABT-888 as part of a single- or limited-dosing study allowed
• Prior cyclophosphamide allowed
• No concurrent protease inhibitors for HIV-positive patients
• ECOG performance status (PS) 0–2 OR Karnofsky PS 60–100%
• Absolute neutrophil count ≥ 1,500/mm^³
• Platelet count ≥ 100,000/mm^³
• Total bilirubin < 1.5 x upper limit of normal (ULN)
• AST and ALT ≤ 2.5 x ULN
• Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing; fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No medical condition that would preclude study participation
• No history of seizures
• No gastrointestinal condition that may predispose patient to drug intolerability or poor drug absorption

---

Treatment Plan:

This is a multicenter, dose-escalation study of ABT-888.

• Patients receive oral ABT-888 once daily for 7-21 days and oral cyclophosphamide once daily for 14 or 21 days
• Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Blood samples are collected periodically
• After completion of study therapy, patients are followed for 30 days

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 
Updated: 1/15/09