Stage IV Surgery Versus Best Medical Therapy



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:November 2009
Contact:Stacey Stern
Email:sterns@jwci.org
Phone:310-998-3982

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A Phase III, Randomized Trial of Surgical Resection With or Without BCG Versus Best Medical Therapy as Initial Treatment in Stage IV Melanoma


This study will establish the role of surgical versus nonsurgical approaches in patients
whose melanoma has spread to distant sites. Results will help clinicians develop a
standardized initial approach that prolongs survival and optimizes quality of life. Results
also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy
significantly improves the outcome of patients treated with surgery.


This study is designed to examine the impact of surgical resection versus medical therapy as
initial treatment therapy for patients with Stage IV melanoma. Surgical resection is thought
to be efficacious in highly selected patients with solitary metastases, but not in patients
with multiple sites of metastases. Even in those with solitary metastases, there is
considerable debate among major melanoma centers over whether undergoing initial systemic
medical therapy prior to surgical resection should be preferred to initial surgical
resection upon Stage IV diagnosis. According to Dr. Dan Coit, Co-leader of the Melanoma
Disease Management Team at Memorial Sloan Kettering Cancer Institute in New York, a trial of
initial medical therapy is their standard approach on the multidisciplinary melanoma service
even for patients with solitary distant metastases (personal communication, 15 Dec 2009).

Many who favor upfront medical therapy believe that delay before surgical resection may
avoid unnecessary surgery by identifying patients who progress early due to the outgrowth of
occult metastases at multiple sites, which may make the patient unresectable.

This is a Phase III, randomized, international, multicenter study of metastasectomy with or
without BCG versus best medical therapy as initial therapy in Stage IV melanoma. This study
has three arms: surgical resection plus BCG as an immune adjuvant, surgical resection plus
observation, and best medical therapy (BMT). Since no systemic medical therapy has been
demonstrated to be superior to DTIC and multiple new therapies are being evaluated, the
choice as to what constitutes best medical therapy will be determined by the individual
investigator based on the standard of care for systemic medical therapy at that particular
multicenter site. Best systemic medical therapy may include clinical trials of new agents or
standard non-protocol treatments (e.g., DTIC or Temodar according to the standard of care at
the multi-center site).

Patients who progress on the best medical treatment arm may switch to a different medical
therapy or, if appropriate, have surgical therapy; similarly, surgery patients may have
additional surgical resection or receive medical therapy.

Inclusion Criteria:

- Patients must provide informed written consent for participation.

- At least 18 years of age

- Have a minimum life expectancy (excluding melanoma) of 5 years.

- All known disease must be surgically resectable in the opinion of a participating
surgeon.

- Must have a histologic diagnosis of Stage IV melanoma arising from a primary
cutaneous site or visceral metastasis from an unknown primary site and be within 4
months of initial stage IV diagnosis.

- Up to 3 visceral organs involved

- Up to 6 lesions allowed

- Must have ECOG performance status of 0 or 1.

- Must be in good general health with no serious co-morbid illness. Good clinical
judgment must be exercised in careful selection of patients who are candidates for
surgical resection of distant metastases.

- Laboratory values within 30 days of randomization:

1. WBC >3,000/mm3

2. Lymphocytes >800/mm3

3. Platelets >100,000/mm3

4. Creatinine <2.0 mg/dL

5. Bilirubin <2.0 mg/dL

6. Alkaline phosphatase < 2X upper limit of normal (ULN)

7. SGOT < 2X ULN

8. SGPT < 2X ULN

9. LDH < 1.5X ULN

Exclusion Criteria:

- Unresectable metastatic disease or more than 4 months since stage IV diagnosis.

- Brain or bone metastatic sites.

- History of primary uveal or mucosal melanoma.

- Another concomitant diagnosis that limits life expectancy to less than 5 years.

- Chronic immunosuppression due to inherited, acquired or iatrogenic immune defect.
This includes active HIV, hepatitis, or use of immunosuppressive medications as a
component of anti-rejection therapy for organ transplant, as treatment for an
autoimmune disease.

- More than 3 involved visceral organ sites or more than 6 metastatic lesions.

- Psychiatric disorder or organic brain syndrome that might preclude participation in
the protocol.

- Diagnosis of other malignancy in the past 5 years except adequately treated low grade
malignancies such as basal cell carcinoma, cutaneous squamous cell carcinoma,
carcinoma-in-situ of the cervix, or other neoplasm that will not limit life
expectancy to less than 5 years.

- Serious cardiac, gastrointestinal, hepatic or pulmonary disease that would make
surgical resection high-risk.

- Pregnancy
We found this trial at
19
sites
13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
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Aurora, CO
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3525
Lakeland, Florida 33805
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Lakeland, FL
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Santa Monica, CA
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Buffalo, New York
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Buffalo, NY
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Charlotte, North Carolina 27157
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Charlotte, NC
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Chicago, Illinois 60612
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Chicago, IL
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Dallas, TX
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Dallas, Texas 75235
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Danville, Pennsylvania 17882
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Danville, PA
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Hershey, Pennsylvania 17033
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Hershey, PA
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Los Angeles, California 91101
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Los Angeles, CA
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Murray, UT
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New Orleans, Louisiana 70121
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New Orleans, LA
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Sacramento, California 95817
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Sacramento, CA
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Salt Lake City, UT
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Wynnewood, Pennsylvania 19096
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Wynnewood, PA
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