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Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma



- 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
with advanced unresectable melanoma.


- Evaluate the duration of response, time to progression, and overall survival of
patients treated with this regimen.

- Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4,
and IL-10) in these patients.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV over 3 hours on day 1 and sargramostim (GM-CSF)
subcutaneously on days 4-17. Treatment repeats every 21 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity. Patients achieving complete
response (CR) receive 2 additional courses of therapy beyond CR for up to 12 courses.

After study treatment, patients are followed every 3-6 months for at least 3 years.

PROJECTED ACCRUAL: A total of 42 patients will accrued for this study.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical response by CT scans every 6 weeks

Safety Issue:


Principal Investigator

William W. Grosh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



University of Virginia Cancer Center Charlottesville, Virginia  22908