Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer

NCT00446368 | Completed Phase 2

• 2 other identifiers: PAC IRB#03-0183-05RCC-RAD-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma, Renal Cell

Keywords

metastatic kidney cancer; metastatic renal cell cancer

Outcome Measures

Primary Outcomes (1)

• To collect data on time to tumor progression produced by the study treatment.

  restaging every 8 weeks

Secondary Outcomes (5)

• Response rate

  restaging every 8 weeks

• Duration of tumor response

  restaging every 8 weeks

• Safety and toxicity

  AEs as occur

• Six month and 12 month survival rate

  at 6 months and at 12 months

• Overall survival

  restaging every 8 weeks

Study Arms (1)

RAD001

EXPERIMENTAL

Subjects will take RAD001 (Everolimus) 10mg by mouth daily.

Drug: RAD001

Interventions

RAD001 DRUG

Participant will take RAD001 (Everolimus) 10mg by mouth once a day.

Also known as: Everolimus

RAD001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Novartis: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Robert J Amato, DO

  Baylor College of Medicine - Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: May 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)