Everolimus in Treating Patients With Stage IV Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00098553
First received: December 7, 2004
Last updated: July 9, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Drug: everolimus
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Proportion of patients with progression-free disease at 16 weeks [ Time Frame: at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: April 2005
Study Completion Date: February 2010
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: everolimus

Detailed Description:

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.

  Eligibility

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

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
  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: NCT00098553

  Show 94 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
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
  More Information

Additional Information:
Publications:
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.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00098553     History of Changes
Other Study ID Numbers: NCCTG-N0377, NCI-2012-02640, CDR0000402871
Study First Received: December 7, 2004
Last Updated: July 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
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 September 01, 2015