Clinical trial NCT00577382: SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
Official title: A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucosal Lentiginous Melanoma
Acral Lentiginous Malignant Melanoma
Keywords: Sutent
malignant melanoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
name: Pfizer
First posted: 2007-12-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 2-month Progression-free Survival Rate
timeFrame: 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:
measure: Best Overall Response Rate
timeFrame: 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.
measure: Overall Survival
timeFrame: 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).
measure: Time to Progression
timeFrame: 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).
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Dana-Farber Cancer Institute
name: F. Stephen Hodi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.