Status:
COMPLETED
A Study Inhibiting Telomerase to Reverse Trastuzumab Resistance in HER2+ Breast Cancer
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Breast Cancer Research Foundation
Geron Corporation
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A study to evaluate safety and biologic effects of giving GRN163L in combination with trastuzumab in patients diagnosed with HER2+ metastatic breast cancer that is resistant to therapy with trastuzuma...
Eligibility Criteria
Inclusion
- Males or females 18 years or older at the time of consent.
- ECOG performance status of 0-2 within 21 days of study registration.
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. NOTE: locally recurrent disease must not be amenable to surgery or radiation with curative intent.
- Measurable or evaluable disease according to RECIST v1.1 within 35 days prior to study registration.
- Disease must be amenable to biopsy (image-guided or via direct visualization of superficial lesions) with minimal risk to the patient. NOTE: Patients with disease limited to the lung and/or pleura are excluded.
- Disease must be HER2+ as defined by IHC 3+ or FISH ratio \> 2.0.
- Resistant to trastuzumab as defined as (1) progression within 12 months of completing adjuvant/neoadjuvant trastuzumab or (2) progression on trastuzumab administered for metastatic disease.
- Prior treatment with lapatinib or investigational HER2 targeted therapies is allowed but not required. There are no limits on the number of regimens or other prior anti-HER2 therapies patients have received.
- LVEF ≥ Lower Limit of Normal based on MUGA or ECHO within 35 days prior to study registration
- Females of childbearing potential and males must be willing to use an effective method of contraception from the time consent is signed until 6 months after treatment discontinuation. Methods of contraception include hormonal birth control (oral contraceptives, patch, injection, vaginal ring or implant), two barrier methods of birth control, abstinence and/or other methods as determined by the treating physician.
- Females of childbearing potential must have a negative pregnancy test within 14 days prior to registration for protocol therapy.
- NOTE: Females are considered of child bearing potential unless they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal (\> 12 months since last menses).
- Laboratory values must be obtained within 21 days of study registration:
- Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
- Platelets ≥ 100 K/mm3
- Hemoglobin (Hgb) ≥ 9.0 g/dL (may be transfused)
- Serum creatinine \< 3.0 mg/dL
- Total Bilirubin ≤ 1.5 x ULN
- AST/SGOT ≤ 2.5 x ULN. If liver metastases is present, AST ≤ 5 x ULN
- ALT, SGPT ≤ 2.5 x ULN. If liver metastases is present, ALT ≤ 5 x ULN
Exclusion
- No Investigational therapy within 4 weeks of study registration
- No hormonal therapy within 2 weeks of study registration
- No cytotoxic chemotherapy within 2 weeks of study registration.
- No prior treatment with GRN163L
- No prior history of severe reaction to trastuzumab, as determined by the treating physician.
- No history of clinically significant cardiac dysfunction, including:
- Current uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg), or unstable angina History of symptomatic CHF (Grade \>3 by NCI CTCAE or Class \>II by NYHA criteria \[see Appendix IV\]) or serious cardiac arrhythmia requiring treatment within 12 months of study registration, with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia History of myocardial infarction within 6 months of study registration
- No history of cerebrovascular accident within 12 months of study registration
- No active CNS metastases. Patients with previously treated CNS metastases who do not require chronic steroids or anticonvulsants are eligible.
- Prior radiation therapy must not have involved \> 25% of bone marrow due to potential myelosuppression with GRN163L. See bone marrow chart in Appendix III
- NOTE: Radiation therapy within 2 weeks of study registration is not allowed.
- Females must not be breastfeeding.
- No clinically significant active infection, as determined by the treating physician
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01265927
Start Date
January 1 2011
End Date
October 1 2015
Last Update
October 27 2015
Active Locations (1)
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1
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202