Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Meta… (NCT01537107) | Clinical Trial Compass
CompletedPhase 1
Sirolimus and Vismodegib in Treating Patients With Solid Tumors or Pancreatic Cancer That is Metastatic or Cannot Be Removed By Surgery
United States31 participantsStarted 2012-03-05
Plain-language summary
This phase I trial studies the side effects and the best dose of sirolimus when given together with vismodegib in treating patients with solid tumors or pancreatic cancer that is metastatic or cannot be removed by surgery. Sirolimus and vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* COHORT I (DOSE ESCALATION): histologic proof of cancer that is now unresectable, not amenable to any other standard therapies, or patient refuses standard therapy
* COHORT II (MTD): metastatic adenocarcinoma of the pancreas and tumor amenable to biopsies; prior systemic treatment for metastatic disease is allowed
* Absolute neutrophil count (ANC) =\> 1500/uL
* Platelet \>= 100,000/uL
* Total bilirubin =\< upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 x ULN
* Creatinine =\< 1.5 x ULN
* Hemoglobin \>= 9.0 g/dL
* Prothrombin time (PT)/international normalized ratio (INR) \< 1.25 x ULN (Cohort II \[MTD\] only)
* Cholesterol \< Common Terminology Criteria for Adverse Events (CTCAE) grade 3
* Triglycerides \< CTCAE grade 2
* Magnesium \>= lower limit of normal (LLN) and =\< ULN
* Ability to provide informed consent
* Willing to return to Mayo Clinic for follow up
* Life expectancy \>= 12 weeks
* Cohort II (MTD) only - Translational Research: Willing to provide the biologic specimens as required by the protocol; Note: this is part of the mandatory translational research component
* Women of childbearing potential only: Negative serum pregnancy test done =\< 7 days prior to registration; NOTE: female subjects who are pregnant or nursing are excluded from this study; there is no specific mitigation strategy for vismodegib toxicity; however, male patients should be made aware of it during the…
What they're measuring
1
MTD (Cohort I) ) and toxicity profile of combination of vismodegib plus sirolimus every 28 days.