RAD001 And Temozolomide In Patients With Advanced Pancreatic Neuroendocrine Tumors

Study Overview

RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

This research study will test the safety of RAD001 in combination with temozolomide.

* Participants will take RAD001 by mouth daily. They will also take temozolomide by mouth daily for one week, followed by a one-week break period. This one-week on/one week off schedule for temozolomide will continue for the duration of the treatment. * After the first month of treatment, there will be a 7-day observation period during which no study medication will be taken to observe for any side effects. * During all treatment cycles (1 cycle is 28 days in length) participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be experiencing. Initially, participants will come in every other week. At each of these visits, blood work will be taken to monitor the participants health. * After every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working.

Pancreatic Neuroendocrine Tumor

DRUG: RAD001
DRUG: Temozolomide

07-325

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-12-17	Results First Submitted 2020-04-24	Last Update Submitted that met QC Criteria 2020-06-26
First Submitted that Met QC Criteria 2007-12-18	Results First Submitted that Met QC Criteria 2020-06-26	Last Update Posted (ACTUAL) 2020-07-09
First Posted (ACTUAL) 2007-12-19	Results First Posted 2020-07-09	Last Verified 2020-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Temozolomide with RAD001	DRUG: RAD001 Given orally once a day DRUG: Temozolomide Taken orally once a day for one week followed by a one-week break period

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Temozolomide with RAD001

DRUG: RAD001

Given orally once a day

DRUG: Temozolomide

Taken orally once a day for one week followed by a one-week break period

Primary Outcome Measures	Measure Description	Time Frame
Response Rate	To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.	2 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free Survival	To determine progression-free survival when RAD001 is given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Progression-free survival is defined as time from start of therapy until disease progression, as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or death.	2 years
To Determine the Safety and Tolerability of This Drug Combination.	To determine the safety and tolerability of RAD001 when given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors.	2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Locally unresectable or metastatic pancreatic neuroendocrine tumor
Radiologic, operative, or pathology reports should document a pancreatic location of tumor
Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated
18 years of age or older
Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine
No Prior therapy with RAD001 or any other mTOR inhibitor
ECOG Performance status 0,1 or 2
Life expectancy 12 weeks or more
Adequate bone marrow, liver and renal function as outlined in the protocol
Negative serum pregnancy test
Fasting serum cholesterol as outlined in protocol

Prior treatment with any investigational drug within the preceding 4 weeks
Chronic treatment with systemic steroids or another immunosuppressive agent
Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
Women who are pregnant or breast feeding
Patients who have received prior treatment with an mTOR inhibitor or temozolomide
Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
History of noncompliance to medical regimens

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Schering-Plough

Investigators

PRINCIPAL_INVESTIGATOR: Jennifer Chan, MD, PhD, Dana-Farber Cancer Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record