Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

NCT ID: NCT00278122

Last Updated: 2013-12-10

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

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, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

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 with advanced unresectable melanoma.

Secondary

• 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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sargramostim

Intervention Type: BIOLOGICAL

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia Cancer Center

Principal Investigators

William W. Grosh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

UVACC-MEL-46

Identifier Type: -

Identifier Source: secondary_id

UVACC-HIT-028.8

Identifier Type: -

Identifier Source: secondary_id

UVACC-PRC-350-04

Identifier Type: -

Identifier Source: secondary_id

11782

Identifier Type: -

Identifier Source: org_study_id