Veliparib + Topotecan ± Carboplatin for Leukemia

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Antiretrovirals, ABT-888

Disqualifiers: CNS leukemia, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28-63 days per course, up to 6 courses

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial is studying the side effects and best dose of veliparib when given together with topotecan hydrochloride with or without carboplatin in treating patients with relapsed or refractory acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan hydrochloride and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with topotecan hydrochloride and carboplatin may kill more cancer cells.

Research Team

Keith W Pratz

Principal Investigator

Johns Hopkins University/Sidney Kimmel Cancer Center

Eligibility Criteria

This trial is for patients with certain blood cancers like acute leukemia, high-risk myelodysplasia, or aggressive myeloproliferative disorders who have relapsed or didn't respond to previous treatments. Participants must be physically stable enough to consent and follow the protocol, not have had more than three prior chemotherapy regimens, and should not be pregnant or breastfeeding. They must use effective contraception during the study.

Inclusion Criteria

I have waited the required time since my last cancer treatment.

My brain leukemia has been stable for over 3 months after treatment.

I have chronic myelomonocytic leukemia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive veliparib orally twice daily on days 1-8, 1-14, or 1-21 and topotecan hydrochloride with or without carboplatin IV continuously over 120 hours on days 3-7. Treatment repeats every 28-63 days for up to 6 courses.

28-63 days per course, up to 6 courses

Pharmacokinetic Studies

Patients undergo blood sample collection periodically for pharmacokinetic studies.

Throughout treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Carboplatin
• Topotecan Hydrochloride
• Veliparib

Trial Overview The trial is testing how well veliparib works alongside topotecan hydrochloride with or without carboplatin in treating specific blood cancers. Veliparib blocks enzymes that cancer cells need to grow while the other drugs aim to kill cancer cells by stopping their division.

Participant Groups

Group I: Treatment (veliparib, topotecan hydrochloride, carboplatin) Experimental Treatment 4 Interventions

Patients receive veliparib orally twice daily on days 1-8, 1-14, or 1-21 and topotecan hydrochloride with or without carboplatin IV continuously over 120 hours on days 3-7. Treatment repeats every 28-63 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+