SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

NCT00577382 | Completed Phase 2 Results DMC

• 1 other identifier: 06-145
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate how effective Sunitinib works in treating acral lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work by blocking signals on certain cancer cells which allow the malignant cells to multiply and spread due to a change in the genetic make up of the cancer cell.

Conditions

Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma

Keywords

Sutent; malignant melanoma

Outcome Measures

Primary Outcomes (1)

• 2-month Progression-free Survival Rate

  2-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 2 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued for 12 months unless disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 2 months.

Secondary Outcomes (3)

• Best Overall Response Rate

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Mean treatment duration was 3 cycles (Cohort A/B mean 2/3 cycles). The range of treatment duration overall was 1-11 cycles.

• Overall Survival

  Patients were followed long-term every 3 months until first progression, death or lost to follow-up. Median survival follow-up was 6.7 months (range 0.8-47.3 months; Cohort A/B median 7.7 m/ 6.2 m).

• Time to Progression

  Disease was evaluated radiologically at baseline and every 8 weeks on treatment and long-term every 3 months until first progression, death or lost to follow-up. Mean treatment duration was 3 cycles (range 1-11; Cohort A/B mean 2/3 cycles).

Study Arms (1)

Sunitinib

EXPERIMENTAL

Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year. Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.

Drug: Sunitinib

Interventions

Sunitinib DRUG

Also known as: Sutent, SU011248

Sunitinib

Eligibility Criteria

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

You may qualify if:

• History of primary mucosal or acral/lentiginous melanoma
• Histologically documented stage III unresectable or IV metastatic melanoma
• ECOG Performance Status 0,1 or 2
• Estimated life expectancy of 6 months or greater
• years of age or older
• Lab values as outlined in protocol
• Tumor blocks or slides must be available of either primary or metastatic tumor site for c-kit mutation testing
• Negative pregnancy test within 48 hours of starting treatment
• At least one measurable site of disease as defined by at least 1cm in greatest dimension

You may not qualify if:

• Severe and/or uncontrolled medical disease
• Pregnant or nursing mothers
• Known brain metastasis. History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan
• Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in situ
• Grade III/IV cardiac problems as defined by the New York Heart Association Criteria
• Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval \>450msec for males of \>470 msec for females
• Hypertension that cannot be controlled by medication
• Any of the following within 12 months prior to starting treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
• NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment
• Concurrent treatment with warfarin
• Prior treatment with SU011248 or any other antiangiogenic agent
• No H2 blockers or proton pump inhibitors
• Known chronic liver disease
• Known HIV infection
• Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 4 weeks prior to study entry

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Beth Israel Deaconess Medical Center: collaborator
• Massachusetts General Hospital: collaborator
• Pfizer: collaborator

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Buchbinder EI, Sosman JA, Lawrence DP, McDermott DF, Ramaiya NH, Van den Abbeele AD, Linette GP, Giobbie-Hurder A, Hodi FS. Phase 2 study of sunitinib in patients with metastatic mucosal or acral melanoma. Cancer. 2015 Nov 15;121(22):4007-15. doi: 10.1002/cncr.29622. Epub 2015 Aug 11.

  PMID: 26264378 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: F. Stephen Hodi, MD
• Organization: Dana-Farber Cancer Institute

Stephen_Hodi@dfci.harvard.edu

617.632.5053

Study Officials

• F. Stephen Hodi, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Melanoma Disease Center Director

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 8, 2016
• Results First Posted: December 8, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)