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RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00576680
Recruitment Status : Active, not recruiting
First Posted : December 19, 2007
Last Update Posted : August 4, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Novartis
Schering-Plough
Information provided by (Responsible Party):
Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Pancreatic Neuroendocrine Tumor Drug: RAD001 Drug: Temozolomide Phase 1 Phase 2

Detailed Description:
  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Study Start Date : May 2008
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017



Intervention Details:
    Drug: RAD001
    Given orally once a day
    Drug: Temozolomide
    Taken orally once a day for one week followed by a one-week break period
    Other Name: Temodar


Primary Outcome Measures :
  1. To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To determine the duration of response to the combination of RAD001 and temozolomide in this patient population. [ Time Frame: 2 years ]
  2. To determine the safety and tolerability of this drug combination. [ Time Frame: 2 years ]
  3. To determine the progression free survival and overall survival of patients receiving this combination. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576680


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
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

Responsible Party: Jennifer Chan, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00576680     History of Changes
Other Study ID Numbers: 07-325
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017

Keywords provided by Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute:
RAD001
temozolomide

Additional relevant MeSH terms:
Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Temozolomide
Dacarbazine
Everolimus
Sirolimus
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic