Clinical trial NCT01989559: Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
Official title: A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Melanoma
Stage IA Skin Melanoma
Stage IB Skin Melanoma
Stage IIA Skin Melanoma
Stage IIB Skin Melanoma
Stage IIC Skin Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2013-11-21
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered \>= 12 months after the last immunization.

II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination \>= 12 months after the last immunization.

III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination \>= 12 months after the last immunization.

IV. To perform detailed studies of the memory T cells persisting \>= 12 months after immunization.

OUTLINE:

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed up at 6 months, every 6 months for 5 years, and then annually thereafter.

Eligibility criteria: Inclusion Criteria:

* Patients must have completed treatment on protocol 99-9 \[T98-0081\] "A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide Vaccine in HLA-A2.1+ Patients with a \> 1mm Melanoma on Initial Biopsy;" 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
* Patients must be \>= 12 months from their last vaccination with gp100 and be free of melanoma; patients who have remained continuously free of disease and patients who have had a recurrence that has been completely resected (stage IV no evidence of disease \[NED\]) are eligible
* Patients must have a good performance status (Karnofsky performance status \[PS\] 80-100)
* White blood cells (WBC) \>= 3500/mm\^3
* Platelets (plt) \>= 100,000/mm\^3
* Hemoglobin \>= 9 gm/100 ml
* Serum creatinine =\< 2 mg/dl
* Total bilirubin =\< 2.0 mg/dl
* Patients must have recovered from any effects of major surgery and be free of significant systemic infection
* Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment; men must avoid fathering a child while on treatment
* Patients must give written informed consent prior to initiation of therapy
* Patients with a history of psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy

Exclusion Criteria:

* Patients must not have clinically detectable melanoma
* Patients who require or are likely to require systemic corticosteroids for intercurrent illness are ineligible
* Patients with any significant medical disease other than the melanoma, which in the opinion of the investigator would significantly increase the risk of immunotherapy, are ineligible
* Patients should be free of any other cancers or deemed at low risk for their recurrence

Primary outcomes:
measure: Percentage of positive CD8+ T cells
timeFrame: Up to 11 years
measure: Change in CD8+ T cell frequency
timeFrame: Up to 11 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Walter Urba
role: PRINCIPAL_INVESTIGATOR
References: