Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Vinorelbine; Docetaxel; Sargramostim
Intervention description: 30 mg/m2 IV over 6-10 min every 14 days; 40mg/m2 IV over 1 hour every 14 days; 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days
Intervention MeSH terms: Docetaxel; Vinorelbine; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Melanoma

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.
    

Eligibility 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