SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

NCT00577382

Last updated date
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- 18 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- Major surgery within 4 weeks prior to study entry


- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
the normal range with medication

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Mucosal Lentiginous Melanoma, Acral Lentiginous Malignant MelanomaSU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
NCT00577382
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Boston, Massachusetts
  4. St. Louis, Missouri
  5. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
Official Title  ICMJE A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
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.
Detailed Description

OBJECTIVES:

Primary

  • To determine the proportion of participants with metastatic mucosal or acral/lentiginous melanoma who are alive and without disease progression at two months after beginning treatment with sunitinib.
  • To determine the best overall response rate.

Secondary

  • To determine the time to progression and overall survival.
  • To correlate c-kit mutational status with response to therapy.
  • To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
  • To assess amplification of c-kit status through quantitative PCR and/or FISH and other related molecular pathway targets.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mucosal Lentiginous Melanoma
  • Acral Lentiginous Malignant Melanoma
Intervention  ICMJE Drug: Sunitinib
Other Names:
  • Sutent
  • SU011248
Study Arms  ICMJE Experimental: Sunitinib

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.

Intervention: Drug: Sunitinib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2007)
50
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 18 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

Exclusion Criteria:

  • 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
  • Major surgery within 4 weeks prior to study entry
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00577382
Other Study ID Numbers  ICMJE 06-145
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party F. Stephen Hodi, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator:F. Stephen Hodi, MDDana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2016

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