A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Theodore Laetsch
- Study ID
- NCT01962896
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Relapsed / Recurrent Germ Cell Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Months - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUG
- Sirolimus — DRUG
Study Details
The purpose of this study is to find out if the combination of an mTOR inhibitor (sirolimus) with an EGFR inhibitor (erlotinib) is effective at treating relapsed or refractory germ cell tumors, and to find out what the side-effects of this regimen are.
Key Dates
- First listed
- Oct 14, 2013
- Start date
- Jan 8, 2014
- Status verified
- Feb 2019
- Primary completion
- Jun 13, 2017
- Completion
- Jan 27, 2018
Study Design
- Enrollment
- 4 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Erlotinib + sirolimus
Primary Outcome Measure
The PFR, Defined as the Proportion of Patients With Refractory Germ Cell Tumors Free of Objective Disease Progression After 4 Cycles (16 Weeks) of Therapy With Erlotinib and Sirolimus [ Time Frame: 16 weeks ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | - |
| UT Southwestern Medical Center/Children's Medical Center | Dallas | Texas | 75390 | - |