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Vaccine Therapy in Treating Patients With Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052988
First received: January 27, 2003
Last updated: May 14, 2013
Last verified: September 2003
History of Changes
  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 Intervention Phase
Melanoma (Skin)
 Biological: HPV 16 E7:12-20 peptide vaccine
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
Procedure: adjuvant therapy
 Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2002
Detailed Description:

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 day 1 and between days 25-30 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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  • No concurrent systemic corticosteroids for intercurrent illness

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052988

Locations
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Sponsors and Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute
National Cancer Institute (NCI)
Investigators
Study Chair: Walter J. Urba, MD, PhD Providence Cancer Center, Earle A. Chiles Research Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00052988     History of Changes
Other Study ID Numbers: CDR0000258479, PPMC-IRB-02-63, NCI-5925
Study First Received: January 27, 2003
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I melanoma
stage II melanoma
stage III melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Adjuvants, Immunologic
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013