Melanoma (Skin)Phase 2NCT00003828
S9804: Vinorelbine in Treating Patients With Stage IV Melanoma
A Phase 2 study testing vinorelbine in people with Melanoma (Skin), run by SWOG Cancer Research Network at 86 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 86 sitesUnited States
- Study dates
- May 1999to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed, pathologically verified, disseminated stage IV melanoma that is surgically incurable Any T, any N, M1a or M1b Must have received at least one prior chemotherapy, biologic/immunotherapy, or combination regimen for metastatic disease At least 4 weeks since prior systemic therapy Bidimensionally measurable disease by physical exam, CT scan, radionuclide scan, or plain x-ray outside previously irradiated area No brain metastases by MRI or CT scan (except completely resected brain tumors that have undergone whole brain radiotherapy)
PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years, except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer Carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior adjuvant biologic or immunotherapy Chemotherapy: See Disease Characteristics No prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
Trial locations and contacts
86 sites in 1 country.
86 sites in 1 country
United States86 sites
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
CCOP - Columbus
Columbus, Ohio, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
University of Colorado Cancer Center
Denver, Colorado, 80262
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Beckman Research Institute, City of Hope
Duarte, California, 91010
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of Texas Medical Branch
Galveston, Texas, 77555-1329
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
CCOP - Dayton
Kettering, Ohio, 45429
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Texas Tech University Health Science Center
Lubbock, Texas, 79423
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153
MBCCOP - University of South Alabama
Mobile, Alabama, 36688
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center
Orange, California, 92868
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Program
Portland, Oregon, 97213
University of California Davis Medical Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Hospital - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Central Illinois
Springfield, Illinois, 62526
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center
Tucson, Arizona, 85724
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.
Read the detailed description
OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients.
OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- vinorelbine
- Keywords
- stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vinorelbineDrug
Also called navelbine
| Study group | Role | What they receive |
|---|---|---|
| vinorelbine | Experimental | vinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes Receives: Drug: vinorelbine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2004 (estimated)
- Study startMay 1999
- Primary completionDec 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert P. Whitehead, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003828
- Sponsor's protocol ID
- CDR0000066983
- Other IDs
- S9804, U10CA032102
- Status last verified
- Aug 2012
- First submitted
- 1 Nov 1999
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Whitehead RP, Moon J, McCachren SS, Hersh EM, Samlowski WE, Beck JT, Tchekmedyian NS, Sondak VK; Southwest Oncology Group. A Phase II trial of vinorelbine tartrate in patients with disseminated malignant melanoma and one prior systemic therapy: a Southwest Oncology Group study. Cancer. 2004 Apr 15;100(8):1699-704. doi: 10.1002/cncr.20183.
PubMed 15073859Moon J, Whitehead RP, McCachren S, et al.: Evaluation of vinorelbine tartrate (Navelbine) in patients with dissemminated malignant melanoma and at least one prior systemic therapy, phase II: a Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1386, 2002.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT00003828
- Acronym / sponsor ID
- CDR0000066983
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1999
- Primary completion
- Dec 2001 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 4 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.
Detailed description
OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients.
OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vinorelbine | Experimental | Drug: vinorelbinevinorelbine 30 mg/m2/week IV bolus over approximately 6-10 minutes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vinorelbineAlso: navelbine | Drug | vinorelbine |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
- Results publication: PubMed 15073859Whitehead RP, Moon J, McCachren SS, Hersh EM, Samlowski WE, Beck JT, Tchekmedyian NS, Sondak VK; Southwest Oncology Group. A Phase II trial of vinorelbine tartrate in patients with disseminated malignant melanoma and one prior systemic therapy: a Southwest Oncology Group study. Cancer. 2004 Apr 15;100(8):1699-704. doi: 10.1002/cncr.20183.
- Results publicationMoon J, Whitehead RP, McCachren S, et al.: Evaluation of vinorelbine tartrate (Navelbine) in patients with dissemminated malignant melanoma and at least one prior systemic therapy, phase II: a Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1386, 2002.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P. Whitehead, MD study chair
University of Texas
86 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vinorelbine in people with Melanoma (Skin), run by SWOG Cancer Research Network at 86 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003828, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.