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

Primary Purpose

Melanoma (Skin)

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sargramostim
paclitaxel
Sponsored by
University of Virginia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Cancer Center

Outcomes

Primary Outcome Measures

Clinical response by CT scans every 6 weeks

Secondary Outcome Measures

Duration of response by CT scans every 6 weeks
Time to progression by CT scans every 6 weeks
Survival

Full Information

First Posted
January 16, 2006
Last Updated
December 9, 2013
Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00278122
Brief Title
Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Official Title
Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Suspended
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Clinical response by CT scans every 6 weeks
Secondary Outcome Measure Information:
Title
Duration of response by CT scans every 6 weeks
Title
Time to progression by CT scans every 6 weeks
Title
Survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William W. Grosh, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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