This phase II trial investigates how well pamiparib and temozolomide work in treating
patients with hereditary leiomyomatosis and renal cell (kidney) cancer. Poly adenosine
diphosphate-ribose polymerase (PARPs) are proteins that help repair DNA mutations. PARP
inhibitors, such as pamiparib, can keep PARP from working, so tumor cells can't repair
themselves, and they may stop growing. Chemotherapy drugs, such as temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving pamiparib and temozolomide may
help treat patients with hereditary leiomyomatosis and renal cell cancer.
I. Evaluate response rate of pamiparib plus low-dose temozolomide.
I. To evaluate the progression-free survival with pamiparib plus low-dose temozolomide.
II. To evaluate the safety (adverse events [AE's]) with pamiparib plus low-dose temozolomide.
I. To determine the association between plasma and tumor 2-hydroxyglutarate (2HG), fumarate,
and succinate levels and response to treatment.
II. To analyze the association of the genomic mutational signature (by whole genome
sequencing) of the tumor to treatment.
Patients receive orally (PO) twice daily (BID) on days 1-28 and temozolomide PO once daily
(QD) on days 1-7. Cycles repeat every 28 days for up to 36 months in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months.
Malignant neoplasm of kidney, Renal Cell Carcinoma, Adenocarcinoma, Malignant Adenoma, prcc, Hereditary Papillary Renal Cell Carcinoma, Tubulocystic Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Unclassified Renal Cell Carcinoma, Kidney Cancer, Unresectable Renal Cell Carcinoma, Metastatic Kidney Cancer, papillary renal cell carcinoma, Stage IV Renal Cell Cancer AJCC v8, Hereditary Leiomyomatosis and Renal Cell Carcinoma, Renal Cell Cancer, Clear Cell Papillary Renal Neoplasm, Renal Cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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