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

Phase 3

Completed

• Conditions: melanoma; skin cancer; 10014982

• Registration Number: NL-OMON36748
• Lead Sponsor: John Wayne Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria
All of the following inclusion criteria must be met and certification of eligibility must be
obtained from the Principal Investigator in order for the patient to be eligible. A completed,
signed and dated consent form is also required prior to randomization and prior to the
performance of any protocol-related procedures.;1. Patients must be at least 18 years of age and have a minimum life expectancy
(excluding melanoma) of 5 years.
2. All known disease must be surgically resectable in the opinion of a participating
surgeon.
3. Patients 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.
4. Patients may have up to 3 visceral organs involved. Any number of lesions up to
6 is allowed.
5. Patients must provide informed written consent for participation.
6. Patients must have ECOG performance status of 0 or 1.
7. Patients 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.
8. Laboratory values within 30 days of randomization:
a. WBC >3,000/mm3
b. Lymphocytes >800/mm3
c. Platelets >100,000/mm3
d. Creatinine <2.0 mg/dL
e. Bilirubin <2.0 mg/dL
f. Alkaline phosphatase < 2X upper
g. SGOT < 2X ULN
h. SGPT < 2X ULN
i. LDH < 1.5X ULN

Exclusion Criteria

Exclusion Criteria
If any of the following exclusion criteria is met, the patient is ineligible for the study.
1. Unresectable metastatic disease or more than 4 months since stage IV
diagnosis.
2. Brain or bone metastatic sites.
3. History of primary uveal or mucosal melanoma.
4. Another concomitant diagnosis that limits life expectancy to less than 5 years.
5. 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.
6. More than 3 involved visceral organ sites or more than 6 metastatic lesions.
7. Psychiatric disorder or organic brain syndrome that might preclude participation
in the protocol.
8. 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.
9. Serious cardiac, gastrointestinal, hepatic or pulmonary disease that would make
surgical resection high-risk.
10. Pregnancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study is open to patients with Stage IV metastatic melanoma who are able<br /><br>to have all sites of known disease surgically removed or ablated and have<br /><br>metastases in no more than 3 visceral organs. Patients with brain or bone<br /><br>metastases are not eligible for the study. Eligibility<br /><br>for resection must be confirmed by a participating surgeon who confirms the<br /><br>potential to resect all known disease.</p><br>