Melanoma (Skin)Phase 2NCT00019721
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
A Phase 2 study testing MART-1 antigen, aldesleukin and gp100 antigen in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- MART-1 antigen, aldesleukin and gp100 antigen
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Jun 2003
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma that has failed standard therapy
- Measurable disease
- HLA-A0201 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
- No coagulation disorder
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No major cardiovascular disease
- If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only
Pulmonary:
- No major respiratory disease
Other:
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- No active systemic infection
- No autoimmune disease or immunodeficiency disease
- No primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic therapy
- No prior MART-1 antigen immunization
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- At least 3 weeks since prior endocrine therapy
- No concurrent steroid therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Prior surgery allowed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.
Read the detailed description
OBJECTIVES:
- Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
- Determine the efficacy of these peptides in patients who cannot receive IL-2.
- Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
- Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
- Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a partially randomized study.
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.
- Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
- Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
- Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
- Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
- Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.
Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.
- Conditions
- Melanoma (Skin)
- Being tested
- MART-1 antigen, aldesleukin, gp100 antigen, incomplete Freund's adjuvant
- 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.
MART-1 antigenBiological
aldesleukinBiological
gp100 antigenBiological
incomplete Freund's adjuvantBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startApr 1999
- Study completionJun 2003
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 National Cancer Institute (NCI)The 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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven A. Rosenberg, MD, PhD, Study chair, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019721
- Sponsor's protocol ID
- CDR0000067051
- Other IDs
- NCI-99-C-0092, NCI-T99-0033
- Status last verified
- Aug 2002
- First submitted
- 11 Jul 2001
- Last updated
- 20 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
- ClinicalTrials.gov ID
- NCT00019721
- Acronym / sponsor ID
- CDR0000067051
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Jun 2003 (actual)
- First posted
- 7 Aug 2003 (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 may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.
Detailed description
OBJECTIVES:
- Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
- Determine the efficacy of these peptides in patients who cannot receive IL-2.
- Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
- Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
- Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a partially randomized study.
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.
- Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
- Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
- Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
- Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
- Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.
Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- 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 |
|---|---|---|
| MART-1 antigen | Biological | – |
| aldesleukin | Biological | – |
| gp100 antigen | Biological | – |
| incomplete Freund's adjuvant | 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 20 Jun 2013.
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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.
Steven A. Rosenberg, MD, PhD study chair
NCI - Surgery Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MART-1 antigen, aldesleukin and gp100 antigen in people with Melanoma (Skin), run by National Cancer Institute (NCI) 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 20 Jun 2013. 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 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?
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 20 Jun 2013.