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Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT00446368
First received: March 9, 2007
Last updated: January 30, 2009
Last verified: January 2009
  Purpose

Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • To collect data on time to tumor progression produced by the study treatment. [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
  • Duration of tumor response [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]
  • Safety and toxicity [ Time Frame: AEs as occur ] [ Designated as safety issue: Yes ]
  • Six month and 12 month survival rate [ Time Frame: at 6 months and at 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: restaging every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: May 2005
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RAD001
Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
Other Name: Everolimus

Detailed Description:

Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility criteria are met and they agree to participate. The participant will take RAD001 (Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and 21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests will be done.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have predominantly clear cell renal cancer (75%)
  • Patients must have evidence of metastatic disease. Metastatic disease should not be progressing so as to require palliative treatment (e.g., radiation, surgery, etc), within 4 weeks of enrollment.
  • Patients may have received no more than two prior regimens such as immunotherapy, chemotherapy or molecular targeted agents for renal cell carcinoma with at least 1 regimen consisting of a tyrosine kinase inhibitor (sorafenib or sunitinib). Four weeks must have elapsed from previous therapy.
  • Patients must have adequate physiologic reserves as evidenced by lab values
  • Effective birth control must be practiced by both male and female patients

Exclusion Criteria:

  • Patients with central nervous system metastases are excluded, except those patients who have had complete excision or radiotherapy and remain asymptomatic, off steroids for 21 days, with no evidence of new disease as shown by MRI
  • Patients known to be HIV positive are not eligible, although testing specifically for participation in this protocol is not required.
  • Patients with a recent history of TIA (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism are not eligible.
  • Patients with active autoimmune disease.
  • Patients who have had steroid therapy within the past three weeks.
  • Patients involving concurrent anticancer drug therapy. Any immunosuppressive drugs or any other experimental therapy.
  • Female patients who are pregnant or lactating.
  • The patient has an unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF; uncontrolled arrhythmias; unstable coagulation disorders; or recent myocardial infarction (within 6 months).
  • The patient has received any investigational agent(s) within 4 weeks of study entry.
  • Patients with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count > 50,000 cells/mm3).
  • Patients unable to maintain an absolute neutrophil count (ANC) of < 1,500 cells/mm3.
  • Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
  • Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 3 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446368

Locations
United States, Texas
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Novartis
Investigators
Principal Investigator: Robert J Amato, DO The Methodist Hospital Research Institute
  More Information

No publications provided

Responsible Party: Robert J. Amato, DO, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00446368     History of Changes
Other Study ID Numbers: RCC-RAD-01, 03-0183-05
Study First Received: March 9, 2007
Last Updated: January 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by The Methodist Hospital System:
metastatic kidney cancer
metastatic renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014