Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01989559
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01989559
Study Brief:
Protocol Section:
NCT01989559