Talazoparib + Radiation for Gynecologic Cancers
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byLilie L Lin
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: CYP3A4 inhibitors, P-gp inhibitors
Disqualifiers: Ascites, Hepatic metastases, Brain metastases, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This phase I trial studies the side effects and best dose of talazoparib in combination with radiation therapy and to see how well they work in treating patients with gynecologic cancers that have come back after previous treatment (recurrent). Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving talazoparib in combination with radiation therapy may work better in treating patients with gynecologic cancers.
Will I have to stop taking my current medications?
The trial requires participants to stop taking any cytotoxic chemotherapeutic agents, immunotherapy, biologic therapy, and targeted therapies at least three weeks before starting the study treatment. Additionally, you must avoid certain medications that interact with the study drug, such as CYP3A4 inhibitors and P-gp inhibitors or inducers.
What data supports the effectiveness of the treatment Talazoparib + Radiation for Gynecologic Cancers?
Research shows that various forms of radiation therapy, like intensity-modulated radiotherapy (IMRT) and intraoperative radiation therapy (IORT), can improve local tumor control and reduce side effects in gynecologic cancers. These techniques help target the cancer more precisely, sparing healthy tissue and potentially improving survival rates.
12345Is the combination of Talazoparib and various forms of radiation therapy safe for treating gynecologic cancers?
Research on radiation therapy for gynecologic cancers, including methods like Intensity-Modulated Radiotherapy (IMRT) and Image-Guided Radiotherapy (IGRT), shows that these treatments can reduce certain side effects, like gastrointestinal issues, compared to older methods. However, radiation therapy can still cause a range of side effects, and safety depends on careful targeting and dose management.
56789How is the Talazoparib + Radiation treatment different for gynecologic cancers?
The Talazoparib + Radiation treatment is unique because it combines a drug that targets cancer cell repair mechanisms with advanced radiation techniques to precisely target tumors while sparing healthy tissue. This approach aims to improve local tumor control and potentially enhance survival rates in patients with challenging gynecologic cancers.
45101112Eligibility Criteria
This trial is for patients with certain types of recurrent gynecologic cancers, including ovarian, fallopian tube, primary peritoneal, endometrial, vaginal or cervical cancer. Participants must have adequate blood counts and organ function and not be pregnant or breastfeeding. They should agree to use effective birth control if applicable and not have any serious medical conditions that could interfere with the study.Inclusion Criteria
I have a tumor that can be measured and has not been treated with radiation.
Your recent blood test does not show signs of a specific type of blood disorder called myelodysplastic syndrome or acute myeloid leukemia.
Your serum creatinine level is not more than 1.5 times the upper limit of normal.
+14 more
Exclusion Criteria
I am not taking medications like ketoconazole or ritonavir.
I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.
My cancer has returned in the vagina only, with no spread to lymph nodes or elsewhere.
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive talazoparib orally once daily and undergo radiation therapy 5 days a week for up to 7 weeks
8 weeks
5 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Visits at 1, 3, 6, 9, and 12 months, then every 6 months
Participant Groups
The trial is testing the combination of a drug called Talazoparib with radiation therapy to see how well they work together in treating recurrent gynecologic cancers. The goal is to determine the best dose of Talazoparib when used with radiation therapy and assess their effectiveness.
1Treatment groups
Experimental Treatment
Group I: Treatment (talazoparib, radiation therapy)Experimental Treatment3 Interventions
Patients receive talazoparib PO QD beginning on days -10 to -7 and continuing for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy 5 days a week (Monday-Friday) for up to 7 weeks.
Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇺🇸 Approved in United States as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇦 Approved in Canada as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇯🇵 Approved in Japan as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇳 Approved in China as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
🇨🇭 Approved in Switzerland as Radiation Therapy for:
- Cancer treatment
- Palliative care
- Oropharyngeal cancer
- Breast cancer
- Prostate cancer
- Lung cancer
- Brain tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimore, MD
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Stereotactic Body Radiation Therapy, Intensity-Modulated Radiation Therapy, and Brachytherapy Boost Modalities in Invasive Cervical Cancer: A Study of the National Cancer Data Base. [2022]Our objective was to determine whether stereotactic body radiotherapy (SBRT), intensity-modulated radiation therapy (IMRT), and brachytherapy boost techniques have comparable overall survival in treating cervical cancer when adjusted for known prognostic factors.
Intensity Modulated Radiotherapy (IMRT) in the postoperative treatment of an adenocarcinoma of the endometrium complicated by a pelvic kidney. [2018]Pelvic Radiotherapy (RT) as a postoperative treatment for endometrial cancer improves local regional control. Brachytherapy also improves vaginal control. Both treatments imply significant side effects that a fine RT technique can help avoiding. Intensity Modulated RT (IMRT) enables the treatment of the target volume while protecting normal tissue. It therefore reduces the incidence and severity of side effects.
EROS 2.0 study: evaluation of two interventional radiotherapy (brachytherapy) schedules for endometrial cancer: a comparison of late vaginal toxicity rates. [2022]To compare the late toxicity rates after two different high dose rate (HDR) adjuvant intravaginal interventional radiotherapy (IRT-brachytherapy) dose schedules in stage I-II endometrial cancer.
The role of intraoperative radiation therapy (IORT) in the treatment of locally advanced gynecologic malignancies. [2019]The prognosis in women with locally advanced primary or recurrent gynecologic malignancies is rather poor. Doses of external beam radiation necessary to treat gross or microscopic recurrence among patients surgically treated or previously irradiated exceed what is tolerated by normal structures. In this group of patients, intraoperative radiation therapy (IORT) can be utilized to maximize local tumor control, minimizing the radiation exposure of dose-limiting surrounding structures. Review of the available literature indicates that IORT may improve long-term local control and overall survival in women with pelvic sidewall and/or para-aortic nodal recurrence. The most encouraging results have been reported in the cases of microscopic residual disease, following surgical debulking.
Radiotherapy of Cervical Cancer. [2017]Curative-intent radical radiotherapy of cervical cancer consists of external-beam radiotherapy, brachytherapy, and concomitant chemotherapy with cisplatin. For each element, new developments aim to improve tumor control rates or treatment tolerance. Intensity-modulated radiotherapy (IMRT) has been shown to reduce gastrointestinal toxicity and can be used to selectively increase the radiotherapy dose. Individualized, image-guided brachytherapy enables better adaptation of high-dose volumes to the tumor extension. Intensification of concomitant or sequential systemic therapy is under evaluation.
Problems and solutions in IGRT for cervical cancer. [2020]The contribution of Image-guided Radiotherapy (IGRT) to modern radiotherapy is undeniable, being the way to bring into daily practice the dosimetric benefits of Intensity-Modulated Radiotherapy (IMRT). Organ and target motion is constant and unpredictable at the pelvis, thus posing a challenge to the safe execution of IMRT. There are potential benefits of IMRT in the radical treatment of cervical cancer patients, both in terms of dose escalation and decrease of toxicity. But it is essential to find IGRT solutions to control the aspects that can lead to geographic miss targeting or organs at risk (OAR) overdose. This review seeks to describe the problems and possible solutions in the clinical implementation of IMRT/IGRT protocols to treat intact cervical cancer patients.
Image guided radiation therapy boost in combination with high-dose-rate intracavitary brachytherapy for the treatment of cervical cancer. [2022]The purpose of this study was to demonstrate the dosimetric and clinical feasibility of image guided radiation therapy (IGRT) combined with high-dose-rate (HDR) intracavitary brachytherapy (ICBT) to improve dose distribution in cervical cancer treatment.
Dosimetric comparison of intensity modulated radiotherapy and three-dimensional conformal radiotherapy in patients with gynecologic malignancies: a systematic review and meta-analysis. [2022]To quantitatively evaluate the safety and related-toxicities of intensity modulated radiotherapy (IMRT) dose-volume histograms (DVHs), as compared to the conventional three-dimensional conformal radiotherapy (3D-CRT), in gynecologic malignancy patients by systematic review of the related publications and meta-analysis.
Intensity-modulated radiation therapy in gynecologic malignancies. [2019]Radiation therapy (RT) is commonly used in the treatment of gynecologic malignancies. Unfortunately, RT exposes patients to a wide variety of sequelae. Concerns over toxicity also limit the use of higher doses in select patients. To improve the efficacy of conventional RT and to explore the possibility of dose escalation, we have turned to the use of intensity-modulated RT (IMRT). This report reviews our preclinical studies, implementation, and clinical experience to date with IMRT for gynecologic malignancies.
Concomitant radiotherapy and paclitaxel for high-risk endometrial cancer: first feasibility study. [2015]Postoperative radiotherapy (RT) is the most used adjuvant treatment in high risk endometrial cancer (HREC), and it appears to reduce the incidence of pelvic relapses but doesn't seem to improve survival. Paclitaxel (P) has shown in vitro and clinical activity against endometrial cancer, and it is also a potent radiosensitizer by blocking dividing cells in G2/M phase. This is the first study that verifies the feasibility of a treatment with concomitant weekly chemotherapy and RT to potentially reduce the incidence of local and distant relapses in order to improve survival in HREC.
Use of stereotactic radiosurgery in the treatment of gynecologic malignancies: A review. [2021]Recent retrospective studies have reported the use of stereotactic radiosurgery (SRS) in the treatment of gynecologic cancers. SRS uses real-time imaging and high dose radiation beams attached to precise robotic arms to target malignant lesions while sparing normal tissue. The purpose of this review is to examine the indications for SRS in gynecologic oncology, review the current literature regarding the use of SRS in gynecologic cancers, and identify future directions for research in this area. Literature on stereotactic radiosurgery was reviewed using the PubMed search engine. Articles written in English from 1993-2013 were reviewed, and 20 case series and clinical trials were included. The safety and efficacy SRS has been demonstrated in all gynecologic disease sites including cervical, endometrial, vulvar, vaginal, and ovarian cancers. Indications for its use include non-central pelvic recurrences in previously irradiated patients, complex or non-resectable disease recurrence, and solitary brain metastases. Toxicities are usually mild, though grade 3-4 toxicities have been reported. SRS is a promising second line treatment modality for patients with primary or recurrent disease who cannot undergo standard surgical or radiation therapy. Further research is required to determine optimal dosing and fractionation schedules, delineate appropriate patient populations, and assess longterm morbidity and survival.
Stereotactic body radiotherapy as an alternative to brachytherapy in gynecologic cancer. [2022]Brachytherapy plays a key role in the treatment of many gynecologic cancers. However, some patients are unable to tolerate brachytherapy for medical or other reasons. For these patients, stereotactic body radiotherapy (SBRT) offers an alternative form of treatment.