Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences

Recruiting in Palo Alto (17 mi)

Overseen byMaysa Abu-Khalaf, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of olaparib when given with hyperthermia in treating patients with breast cancer that has come back in the chest wall. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hyperthermia treatment may kill or damage tumor cells by heating them to several degrees above normal body temperature. Giving olaparib and hyperthermia treatment may work better in treating patients with breast cancer that has come back in the chest well compared to standard of care.

Research Team

Maysa Abu-Khalaf, MD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

Inclusion Criteria

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (measured within 28 days prior administration of study treatment)

Platelet count >= 100 x 10^9/L (measured within 28 days prior to administration of study treatment)

Patients must have creatinine clearance estimated of >= 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test (measured within 28 days prior to administration of study treatment)

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Exclusion Criteria

You have received a bone marrow transplant from someone else or a double umbilical cord blood transplant in the past.

You have had cancer in the past, but it has been successfully treated and there has been no sign of it coming back for at least 5 years. There are some types of cancer that are not included in this criteria, such as non-melanoma skin cancer, very early stage cervical cancer, and a specific type of early stage endometrial cancer.

Patients with known active hepatitis B or C

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Treatment Details

Interventions

Hyperthermia Treatment (Procedure)
Olaparib (PARP Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib, hyperthermia)Experimental Treatment4 Interventions

Patients receive olaparib PO BID. Treatment continues for 4 weeks in the absence of disease progression and unacceptable toxicity. Beginning week 2, patients also undergo hyperthermia treatment over 1 hour twice weekly for 3 weeks in the absence of disease progression and unacceptable toxicity.