Status:
ACTIVE_NOT_RECRUITING
Veliparib, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Non-Hodgkin Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of veliparib, cyclophosphamide, and doxorubicin hydrochloride when given together in treating patients solid tumors or non-Hodgkin lymphoma th...
Detailed Description
PRIMARY OBJECTIVES: I. Identify the maximally tolerated dose (MTD) and dose limiting toxicity (DLT) of cyclophosphamide when combined with escalating doses of ABT-888 (veliparib). II. Identify the m...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; patients with either solid tumors or non-Hodgkin's lymphoma are eligible
- At the recommended Phase II dose level, an additional 6 to 12 patients in each group with the following criteria will be enrolled: documented breast cancer (BRCA)1/BRC2 mutation, triple-negative breast cancer defined as estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor (HER)2-negative, or patients who would benefit from a cyclophosphamide-based regimen
- On the schedule of ABT-888 given for 7 or 14 days, only patients with metastatic breast cancer will be enrolled
- Patients must be \>= 4 weeks since prior chemotherapy or radiation therapy (\>= 6 weeks if the last regimen included carmustine \[BCNU\] or mitomycin C); patients previously treated with cyclophosphamide should not be necessarily excluded
- Patients with non-Hodgkin's lymphoma that is amenable to hematopoietic stem cell transplantation with curative intent may participate only if stem cell transplant is refused or is not indicated
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Life expectancy of greater than 2 months
- Hemoglobin \>= 9.0 g/dL
- Absolute neutrophil count (ANC) \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (ULN), =\< 5 x ULN if known hepatic metastases
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 ml/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =\< 1.2 X institutional ULN
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patients enrolled in a group where the treatment is adriamycin and cycloblastin (AC): ejection fraction \>= 50% by multigated acquisition scan (MUGA) or echocardiogram
- Patients must sign informed consent
Exclusion
- Concurrent administration of any other investigational agent(s)
- Prior high-dose therapy requiring hematopoietic stem cell transplantation
- Prior anti-cancer treatments involving radioactive pharmaceuticals
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ABT-888 and/or cyclophosphamide
- Patients receiving any medications or substances that are strong inhibitors or strong inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP 3A4), cytochrome P450, family 2, subfamily B, polypeptide 6 (2B6), cytochrome P450, family 2, subfamily C, polypeptide 9 (2C9) or cytochrome P450, family 2, subfamily C, polypeptide 19 (2C19) are prohibited; at the time of screening, if the patient is currently receiving any of the listed prohibited medication(s), the medication(s) must be discontinued for a period of no less than 7 days prior to administration of the first dose of study medication in order for the patient to meet study eligibility except for the following substance where the washout should be 6 months: amiodarone
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; New York Heart Association (NYHA) grade II or greater congestive heart failure
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ABT-888; these potential risks may also apply to other agents used in this study
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; NOTE: HIV seropositive patients not receiving combination antiretroviral therapy who have cluster of differentiation (CD)4 cells \>= 350/mm\^3, no opportunistic infections and meet all eligibility criteria may participate in this study
- Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain ABT-888 capsules
- Patients with gastrointestinal conditions that might predispose for drug intolerability or poor drug absorption (e.g., inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, malabsorption syndrome, active peptic ulcer disease) are excluded; subjects with ulcerative colitis, inflammatory bowel disease, or a partial or complete small bowel obstruction are also excluded
- Patients with active central nervous system (CNS) metastases are excluded
- Patients with CNS metastases that have been treated must be off steroid treatment for \> 3 months, be asymptomatic and off steroid treatment prior to study enrollment
- Patients that have symptoms to suggest CNS metastases should have a brain magnetic resonance imaging (MRI) within 28 days of enrollment to confirm the absence of CNS metastases; contrast computed tomography (CT) is acceptable for patients who are unable to undergo a brain MRI
- Patients with active seizure or a history of active seizure
- Any other medical, social, or psychological condition that may significantly affect safety and/or compliance
- Patients enrolled in a group where treatment is AC: prior doxorubicin exposure of \> 300 mg/m\^2 or equivalent anthracycline exposure (i.e., epirubicin dose \> 540 mg/m\^2)
Key Trial Info
Start Date :
August 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00740805
Start Date
August 18 2008
End Date
October 22 2026
Last Update
November 6 2025
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903