Vaccine Research |
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Clinical Trial: Vaccine Therapy in Treating Patients With Melanoma
This study is no longer recruiting patients.
Purpose
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: Phase I trial to study the effectiveness of booster vaccinations in preventing cancer recurrence in patients who have melanoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I melanoma stage II melanoma stage III melanoma | Drug: HPV-16 E7(12-20) peptide vaccine Drug: Montanide ISA-51 Drug: gp100 antigen Procedure: adjuvant therapy Procedure: biological response modifier therapy Procedure: recombinant viral vaccine Procedure: vaccine therapy | Phase I |
MedlinePlus related topics: Melanoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Pilot Study of Booster Vaccination With gp100:209-217 (210M) Peptide and HPV-16 E7 (12-20) Peptide Vaccine Emulsified in Montanide ISA-51 in Previously Vaccinated Patients With Melanoma
OBJECTIVES:
- Determine the toxicity of booster vaccination with gp100:209-217 (210M) peptide and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 administered at least 12 months after prior vaccination in patients with melanoma.
- Determine T-cell response to modified gp100: 209-217 (210M) peptide and unmodified native gp100 peptide in these patients.
- Determine T-cell response to the control HLA-A2-restricted CD8 epitope of HPV-16 E7 (12-20) peptide vaccine in these patients.
OUTLINE: Patients undergo leukapheresis on day 0. Patients receive vaccination comprising gp100:209-217 (210M) and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on days 1 and 28 in the absence of disease progression or unacceptable toxicity. Patients undergo a second leukapheresis 2-4 weeks after the second vaccination.
Patients who remain disease free for 6 months after the second vaccination may receive additional booster vaccinations SC every 6 months for 3 years.
Patients are followed at 3 and 6 months after the second vaccination and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.
Eligibility
Ages Eligible for Study: 16 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Completed treatment on PPMC-IRB-99-9*
- At least 12 months since last vaccination NOTE: *Patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose-limiting toxicity
- No current evidence of melanoma, as defined by one of the following:
- Disease-free since completion of PPMC-IRB-99-9
- Recurrence occurred but was completely resected
PATIENT CHARACTERISTICS: Age
- Over 16
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic
- Bilirubin no greater than 2 mg/dL
Renal
- Creatinine no greater than 2 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- No other concurrent medical or psychiatric illness that would preclude study participation
- No concurrent significant systemic infection
- No other concurrent cancer or at low risk for recurrence of prior cancers
PRIOR CONCURRENT THERAPY: Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Concurrent systemic corticosteroids allowed provided they do not interfere with protocol therapy, in the opinion of the principal investigator
Radiotherapy
- Not specified
Surgery
- Recovered from prior major surgery
Location Information
Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center, Portland, Oregon, 97213-2967, United States
Walter John Urba, PhD, MD, Study Chair, Earle A. Chiles Research Institute
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: November 2003
Last Updated: October 13, 2004
Record first received: January 27, 2003
ClinicalTrials.gov Identifier: NCT00052988
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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