Status:
SUSPENDED
Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies...
Detailed Description
OBJECTIVES: Primary * Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective clinical response rate (complete response \[CR\] and partial response \[PR\]), in patients wi...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable stage III or IV melanoma from a cutaneous, mucosal, or unknown primary site
- Unresectable stage III disease, defined as meeting 1 of the following criteria:
- Regional metastasis that, in the judgement of the treating physician, cannot be surgically resected with clear margins
- Regional metastasis that can be surgically resected with clear margins only by extensive surgery that is inadvisable or unacceptable to the treating physician and/or patient
- Staging of cutaneous and mucosal melanoma based on the revised American Joint Committee on Cancer (AJCC) staging system
- Must have measurable disease as defined by Response Evaluation Criteria in Small Tumors (RECIST) criteria
- No ocular melanoma
- Patients with brain metastases may be eligible if all of the following are true:
- Total number of brain metastases ever is ≤ 3
- Each brain metastasis has been completely removed by surgery or each unresected brain metastasis has been treated with stereotactic radiosurgery
- Stereotactic radiosurgery, such as gamma knife, can be used up to 1 week before study entry
- No evident growth of any brain metastasis since treatment
- No brain metastasis that is \> 2 cm in diameter at study entry
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin normal
- Creatinine ≤ 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No previous or concurrent autoimmune disorder requiring cytotoxic or immunosuppressive therapy
- No autoimmune disorder with visceral involvement
- The following conditions are allowed:
- Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring steroidal anti-inflammatory drugs
- HIV negative
- Hepatitis C negative
- No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy
- PRIOR CONCURRENT THERAPY:
- No more than 1 previous chemotherapy regimen for metastatic melanoma
- No previous paclitaxel
- No chemotherapy, interferon, growth factors, interleukin, or radiotherapy (excluding gamma knife therapy for brain metastases) within the past 4 weeks
- No surgical resection of metastatic lesions within the past 4 weeks
- No other investigational medication within the past 4 weeks or during study
- No nitrosoureas (e.g., carmustine or lomustine) within the past 6 weeks and during study treatment
- No other concurrent chemotherapy, interferon, other growth factors, interleukin, illegal drugs, radiotherapy, surgery, or steroid therapy
- No concurrent oral or injectable hydrocortisone (at doses \> 15 mg per day) or its equivalent
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00278122
Start Date
July 1 2005
Last Update
December 10 2013
Active Locations (1)
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1
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908