Melanoma (Skin)Phase 1NCT00003897
Vaccine Therapy With gp100 and/or Sargramostim in Treating Patients With Malignant Melanoma
A Phase 1 study testing gp100 antigen and sargramostim in people with Melanoma (Skin), run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or sargramostim in treating patients who have malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gp100 antigen and sargramostim
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Dec 2006
- Phase
- Phase 1
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven malignant melanoma that is surgically or medically incurable Measurable or evaluable metastatic disease OR No evidence of disease following surgical resection of a distant metastasis OR Surgical resection of at least 2 local or regional recurrences, at least 1 of which had evidence of lymph node involvement Each recurrence at least 1 month apart
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant Fertile patients must use effective contraception HIV negative No active infections requiring antibiotic, antiviral, or antifungal therapy No other active malignancy No concurrent significant illnesses
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior immunotherapy Chemotherapy: At least 1 month since prior chemotherapy No more than 2 prior chemotherapy regimens for melanoma Endocrine therapy: At least 1 month since prior steroids (except intermittent use as antiemetic or as topical agent) No concurrent steroids Radiotherapy: At least 1 month since prior radiotherapy No prior radiotherapy to vaccine site Surgery: No prior organ allografts
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase I Trial of Immunization Using Particle-Mediated Transfer of Genes for GP-100 and GM-CSF Into Uninvolved Skin of Patients With Melanoma (Summary Last Modified 7/1999)
RATIONALE: Vaccines made from gp100 and sargramostim may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or sargramostim in treating patients who have malignant melanoma.
Read the detailed description
OBJECTIVES: I. Determine the safety and toxicity of in vivo particle bombardment with DNA coated gold beads carrying cDNA for gp100, with or without gold beads carrying cDNA for sargramostim (GM-CSF), into uninvolved skin of patients with melanoma. II. Estimate the intensity and duration of gp100 transgene expression following these regimens in these patients. III. Assess local lymphocyte phenotype and systemic lymphocyte function following these regimens in these patients. IV. Compare gp100 transgene expression as well as local lymphocyte phenotype and systemic lymphocyte function when the cDNA for GM-CSF is administered 3 days before cDNA for gp100 vs on the same day as gp100 administration in these patients. V. Determine the effect of these regimens on tumor shrinkage, histological evidence of tumor inflammation or necrosis, or in vitro evidence of antitumor immune reactivity in these patients.
OUTLINE: This is a dose escalation study. Patients are assigned to one of three treatment groups. Group I: Patients receive particle mediated gene transfer (PMGT) of gp100 on day 1 to 2 or 4 separate sites. One site is biopsied on day 3. A second course is administered on day 22 and one of the sites is biopsied on day 26. Delayed type hypersensitivity (DTH) is assessed on days 40 and 43. Group II: Patients receive PMGT of sargramostim (GM-CSF) on day 1 to 1-5 separate sites. PMGT of gp100 is administered to 2-4 of these same sites on day 4. One of the gp100 sites is biopsied on day 6. A second course is administered beginning on day 22, with one of the sites biopsied on day 29. DTH is assessed on days 40 and 43. Group III: Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites. Courses are administered as in group I. Patients who achieve partial or complete response or maintain stable disease may receive another course of therapy. Cohorts of 3-6 patients are treated at each dose in each group until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 3, 6, and 12 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- gp100 antigen, sargramostim
- 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.
gp100 antigenBiological
sargramostimBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2004 (estimated)
- Study startMay 1999
- Primary completionMar 2001
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 1
- Primary purpose
- Treatment
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark R. Albertini, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003897
- Sponsor's protocol ID
- CO98601
- Other IDs
- U01CA061498, CO98601, NCI-T98-0045, A536755, SMPH/PEDIATRICS
- Status last verified
- Jul 2015
- First submitted
- 1 Nov 1999
- Last updated
- 19 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Immunization Using Particle-Mediated Transfer of Genes for GP-100 and GM-CSF Into Uninvolved Skin of Patients With Melanoma (Summary Last Modified 7/1999)
- ClinicalTrials.gov ID
- NCT00003897
- Acronym / sponsor ID
- CO98601
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1999
- Primary completion
- Mar 2001 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 18 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: Vaccines made from gp100 and sargramostim may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy with gp100 and/or sargramostim in treating patients who have malignant melanoma.
Detailed description
OBJECTIVES: I. Determine the safety and toxicity of in vivo particle bombardment with DNA coated gold beads carrying cDNA for gp100, with or without gold beads carrying cDNA for sargramostim (GM-CSF), into uninvolved skin of patients with melanoma. II. Estimate the intensity and duration of gp100 transgene expression following these regimens in these patients. III. Assess local lymphocyte phenotype and systemic lymphocyte function following these regimens in these patients. IV. Compare gp100 transgene expression as well as local lymphocyte phenotype and systemic lymphocyte function when the cDNA for GM-CSF is administered 3 days before cDNA for gp100 vs on the same day as gp100 administration in these patients. V. Determine the effect of these regimens on tumor shrinkage, histological evidence of tumor inflammation or necrosis, or in vitro evidence of antitumor immune reactivity in these patients.
OUTLINE: This is a dose escalation study. Patients are assigned to one of three treatment groups. Group I: Patients receive particle mediated gene transfer (PMGT) of gp100 on day 1 to 2 or 4 separate sites. One site is biopsied on day 3. A second course is administered on day 22 and one of the sites is biopsied on day 26. Delayed type hypersensitivity (DTH) is assessed on days 40 and 43. Group II: Patients receive PMGT of sargramostim (GM-CSF) on day 1 to 1-5 separate sites. PMGT of gp100 is administered to 2-4 of these same sites on day 4. One of the gp100 sites is biopsied on day 6. A second course is administered beginning on day 22, with one of the sites biopsied on day 29. DTH is assessed on days 40 and 43. Group III: Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites. Courses are administered as in group I. Patients who achieve partial or complete response or maintain stable disease may receive another course of therapy. Cohorts of 3-6 patients are treated at each dose in each group until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 3, 6, and 12 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| gp100 antigen | Biological | – |
| sargramostim | Biological | – |
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 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Mark R. Albertini, MD study chair
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gp100 antigen and sargramostim in people with Melanoma (Skin), run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 19 Nov 2019.