Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

Part of paid clinical trials in Orange, California.

Sponsor
John P. Fruehauf
Study ID
NCT00256282
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    30 mg/m2 IV over 6-10 min every 14 days
  • Docetaxel — DRUG
    40mg/m2 IV over 1 hour every 14 days
  • Sargramostim — DRUG
    250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days

Study Details

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.

Key Dates

Start date
Apr 30, 2003
Status verified
Feb 2018
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel & Vinorelbine + Sargramostim
    Docetaxel, Vinorelbine, and Sargramostim

Primary Outcome Measure

Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy [ Time Frame: Six months from initial treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Chao Family Comprehensive Cancer Center· Orange, CA

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