Veliparib + Topotecan ± Carboplatin for Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Keith W Pratz

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, MD

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References