Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John P. Fruehauf; University of California, Irvine
• Collaborator: Bayer
• Treatments: Docetaxel; Sargramostim; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Age greater than or equal to 18

• Karnofsky Performance Status (KFS) of greater than or equal to 70

• Laboratory values (performed in 14 days, inclusive prior to study drug administration):

• Absolute neutrophil count (ANC) >1500/mm3

• Platelet count >100,000/mm3

• Hemoglobin > 10 g/dl

• Blood urea nitrogen (BUN) and serum creatinine < 0.5 times the upper limit of laboratory normal

• Total and direct bilirubin < 1.5 times the upper limit of laboratory normal

• Serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 3 times the upper limit of laboratory normal

• Alkaline phosphatase < 3 times upper limit of laboratory normal

• Life expectancy of greater than 12 weeks

• Written informed consent

Exclusion Criteria:

• No recovery from all active toxicities of prior therapies

• Surgery within 1 week prior to study drug administration, providing acute surgical toxicity is resolved

• Subjects within acute infection treated with intravenous antibiotics

• Frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)

• Concurrent malignancies at other sites with the exception of surgically cured carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin, and prior malignancies which have not required anit-tumor treatment within the preceding 24 months

• Known HIV-positivity or AIDS-related illness

• Women of childbearing potential who are not using an effective method of contraception (eligible patients must have a negative urine pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions)

• Men who do not use an effective method of contraception.

• Chemotherapy within four weeks prior to study drug administration or biologic therapy/immunotherapy within two weeks prior to study drug administration

• Completion of radiation therapy, interstitial brachytherapy, or radiosurgery within 4 weeks prior to study drug administration (patients with brain metastases from melanoma must have completed radiotherapy to the brain at least 3 weeks before study commences)

• Bone metastases as sole reason for Stage IV disease

• Karnofsky Performance Status of less than or equal to 60