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Everolimus in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00098553
First received: December 7, 2004
Last updated: July 1, 2016
Last verified: July 2016

December 7, 2004
July 1, 2016
April 2005
July 2007   (final data collection date for primary outcome measure)
Proportion of patients with progression-free disease at 16 weeks [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00098553 on ClinicalTrials.gov Archive Site
  • Median overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Tumor response rate for 2 consecutive evaluations at least 8 weeks apart [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Toxicity as measured by CTCAE v. 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • disease progression [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Everolimus in Treating Patients With Stage IV Melanoma
Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma

RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.

OBJECTIVES:

Primary

  • Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.

Secondary

  • Determine the median overall survival of patients treated with this drug.
  • Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.
  • Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Drug: everolimus
Experimental: everolimus

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.

Intervention: Drug: everolimus
  • Rao RD, Allred JB, Windschitl HE, et al.: N0377: results of NCCTG phase II trial of the mTOR inhibitor RAD-001 in metastatic melanoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-8530, 479s, 2007.
  • Rao RD, Windschitl HE, Allred JB, et al.: Phase II trial of the mTOR inhibitor everolimus (RAD-001) in metastatic melanoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-8043, 463s, 2006.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
February 2010
July 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma for which no known standard or potentially curative therapy exists or has been proven to extend life expectancy

    • Stage IV disease
  • Measurable disease

    • At least 1 lesion ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan
  • No intracranial disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • No bleeding diathesis

Hepatic

  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 ULN
  • INR ≤ 1.5

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to refrain from foods high in fat content
  • No uncontrolled infection
  • No immunosuppression from any cause (e.g., known HIV infection)
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
  • No other severe condition that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy or biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior sirolimus or its analogues for any indication
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy to head and neck area
  • More than 4 weeks since prior radiosurgery
  • No prior radiotherapy to > 30% of bone marrow
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • At least 1 week since prior and no concurrent CYP3A4 inducers
  • No concurrent warfarin
  • No concurrent cytotoxic agents
  • No other concurrent experimental drugs
  • No other concurrent immunosuppressive therapy
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00098553
NCCTG-N0377, NCI-2012-02640, CDR0000402871
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Ravi D. Rao, MD, MBBS Mayo Clinic
Investigator: Harold E. Windschitl, MD Coborn Cancer Center
Investigator: William J. Maples, MD Mayo Clinic
Investigator: Michael K. Gornet, MD Mayo Clinic
Investigator: James N. Ingle, MD Mayo Clinic
Investigator: Edward T. Creagan, MD Mayo Clinic
Investigator: Judith S. Kaur, MD Mayo Clinic
Investigator: Barbara A. Pockaj, MD Mayo Clinic Hospital
Investigator: Evanthia Galanis, MD Mayo Clinic
Investigator: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Henry C. Pitot, MD Mayo Clinic
Investigator: Lori A. Erickson, MD Mayo Clinic
Investigator: Val J. Lowe, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP