M.D. Anderson Cancer Center
The goal of this clinical research study is to find the highest safe dose of olaparib that can be combined with chemotherapy drugs and stem cell transplantation to treat patients with relapsed and refractory germ cell cancer. The safety and effectiveness of this treatment combination therapies will also be studied.
Primary Objectives: 1. To identify the optimal dose of Olaparib/GemDC and Olaparib/CE with ASCT in patients with R/R GCT. 2. To establish the preliminary efficacy of sequential cycles of Olaparib/GemDC and Olaparib/CE with ASCT in patients with R/R GCT through the primary study endpoint (2-year RFS rate). Secondary Objectives: 1. To establish the safety and describe the toxicity profile of the study treatment. 2. To evaluate the antitumor activity of the study treatment by determining the following secondary endpoints: Overall response rate (ORR) and complete response (CR) rate. 3. To evalu…
Inclusion Criteria: 1. 12 - 60 years of age. 2. Diagnosis of relapsed GCT, with one or more of the following criteria: 1. Extragonadal primary. 2. \>2 prior relapses. 3. Unresponsive disease (PD or SD) to the immediately prior therapy. 3. ECOG PS ≤ 2 (Karnofsky ≥ 60%).in adults, Lansky Play-Performance Scale (LPPS) ≥ 60% in pediatric patients. 4. A minimum apheresis collection of 5 million CD34+ cells/kg of autologous peripheral blood progenitor cells (PBPC). 5. Adequate blood counts (WBC ≥ 2K, HGB ≥ 8 g/dL, platelets ≥ 50K). 6. Creatinine clearance ≥ 50 ml/min/1.73 m2 (estimated by…
Given by mouth twice daily
Given by mouth twice daily
Given by IV
Given by IV
Given by IV
Given by IV
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