RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2019-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RAD001 in Combination With CP-751,871 in Patients Wtih Advanced Sarcomas and Other Malignant Neoplasms

NCT00927966

Sarcoma Solid Tumor

COMPLETED PHASE1

RAD001 in Advanced Hepatocellular Carcinoma

NCT00516165

Hepatocellular Carcinoma

COMPLETED PHASE1/PHASE2

Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas

NCT01048723

Sarcoma

TERMINATED PHASE2

Temozolomide and Everolimus in Treating Patients With Stage IV Melanoma That Cannot be Removed by Surgery

NCT00521001

Melanoma (Skin)

COMPLETED PHASE2

Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs

NCT02943733

Neuroendocrine Tumors Neoplasms Cancer +1 more

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neuroendocrine Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Temozolomide with RAD001

Group Type EXPERIMENTAL

RAD001

Intervention Type DRUG

Given orally once a day

Temozolomide

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RAD001

Given orally once a day

Intervention Type DRUG

Temozolomide

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Temodar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No