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A Clinical Trial to Evaluate a Helper Peptide Vaccine Plus Vemurafenib in Melanoma

Information source: University of Virginia
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: vemurafenib (Drug); 6MHP (Biological)

Phase: Phase 1/Phase 2

Status: Not yet recruiting

Sponsored by: Craig L Slingluff, Jr

Official(s) and/or principal investigator(s):
Elizabeth Gaughan, MD, Principal Investigator, Affiliation: University of Virginia
Craig L. Slingluff, Jr., MD, Study Director, Affiliation: University of Virginia

Overall contact:
Kristy Scott, BS, Phone: 434-982-6714, Email: ks4ww@virginia.edu

Summary

This study evaluates whether it is safe to administer a peptide vaccine with vemurafenib. This study will also evaluate the effects of the combination of the peptide vaccine and vemurafenib on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tumor samples.

Clinical Details

Official title: A Trial to Evaluate the Safety, Immunogenicity, and Clinical Activity of a Helper Peptide Vaccine Plus BRAF Inhibition (Mel61)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Adverse event profile for the combination of vemurafenib and 6MHP

CD4+ T cell responses in the blood and in the sentinel immunized node

Progression-free survival

Secondary outcome:

An evaluation of the infiltration of T cells into melanoma metastases pre and post-vaccination.

Antibody responses against 6MHP

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participants with measurable stage IIIB, IIIC, or IV melanoma that have clinical or

radiological evidence of disease. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Staging must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on the revised AJCC staging system.

- Participants must be eligible to be treated with BRAF inhibitor, based on clinician

judgment within standard of care, including the presence of the BRAFV600E mutation or V600K.

- Participants will be required to have radiological studies to define radiologically

evident disease. Required studies include:

- Chest CT scan,

- Abdominal and pelvic CT scan, and

- Head CT scan or MRI

- PET/CT fusion scan may replace scans of the chest, abdomen, and pelvis.

- Participants who have metastatic melanoma available for biopsy pretreatment and on

day 22 must consent to having those biopsies. These metastases may be in nodes, skin, soft tissue, liver, or other sites that can be accessed by needle biopsy, incisional or excisional biopsy, with or without image guidance. The lesion(s) must be large enough to enable biopsy of at least 0. 1 cm3 of tumor tissue (ideally 0. 3 cm3 or more) in 5 core biopsies (ideally 14-16 gauge, but 18 gauge acceptable) or incisional/excisional biopsies at both time points. The lesions to be biopsied must be specified at study enrollment and not included as target lesions for RECIST calculations. There must be measurable disease in addition to the lesion(s) to be biopsied. It is acceptable to perform a biopsy pretreatment, and then to perform an excision at day 22, even under general anesthesia if needed. Up to 19 participants without metastatic disease available and sufficient for those biopsies may enroll in the study as well. Once that number has completed enrollment, subsequent participants must have biopsiable disease and agree to the biopsies.

- Participants who have had brain metastases will be eligible if all of the following

are true:

- The total number of brain metastases ever ≤ 3

- Each brain metastasis must have been completely removed by surgery or each

unresected brain metastasis must have been treated with stereotactic radiosurgery.

- There has been no evident growth of any brain metastasis since the most recent

treatment

- No brain metastasis is > 2 cm in diameter at the time of registration

- The most recent surgical resections or gamma-knife therapy for malignant

melanoma must have been completed ≥ 1 week and ≤ 6 months prior to registration.

- ECOG performance status of 0 or 1

- Participants must have the ability and willingness to give informed consent

- Laboratory parameters as follows:

- ANC > 1000/mm3

- Platelets > 100,000/mm3

- Hgb > 9 g/dL

- HGB-A1C ≤ 7. 5%

- AST and ALT up to 2. 5 x upper limits of normal (ULN). Patients known to have

Gilbert's disease may be eligible with AST and ALT up to 5 x ULN.

- Bilirubin up to 2. 5 x ULN

- Alkaline phosphatase up to 2. 5 x ULN.

- Creatinine up to 1. 5 x ULN

- LDH up to 1. 5 x ULN

- Age 18 years or older at registration

- Participants must have at least two intact (undissected) axillary and/or inguinal

lymph node basins Exclusion Criteria:

- Participants who have received the following medications or treatments at any time

within 4 weeks of registration:

- Chemotherapy

- Interferon (e. g. Intron-A®)

- Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥

1 week and ≤ 6 months prior to registration)

- Allergy desensitization injections

- Corticosteroids, administered transdermally, parenterally or orally. Inhaled

steroids (e. g.: Advair®, Flovent®, Azmacort®) are not permitted. Topical corticosteroids are acceptable.

- Growth factors (e. g. Procrit®, Aranesp®, Neulasta®)

- Interleukins (e. g. Proleukin®)

- Any investigational medication

- Targeted therapies specific for mutated BRAF or for MEK

- HIV positivity or evidence of active Hepatitis C virus.

- Participants who are currently receiving nitrosoureas or who have received this

therapy 6 weeks prior to registration

- Participants who are currently receiving a checkpoint molecule blockade therapy, or

who have received this therapy within 6 weeks prior to registration.

- Participants with known or suspected allergies to any component of the vaccine.

- Participants may not have been vaccinated previously with any of the synthetic

peptides included in this protocol. Participants who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination.

- Pregnancy. Female participants of childbearing potential must have a negative

pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.

- Female participants must not be breastfeeding

- Participants in whom there is a medical contraindication or potential problem in

complying with the requirements of the protocol in the opinion of the investigator.

- Participants classified according to the New York Heart Association classification as

having Class III or IV heart disease.

- Participants with uncontrolled diabetes, defined as having a HGBA1C ≤ 7. 5%.

- Participants must not have had prior autoimmune disorders requiring cytotoxic or

immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:

- The presence of laboratory evidence of autoimmune disease (e. g. positive ANA

titer) without symptoms

- Clinical evidence of vitiligo

- Other forms of depigmenting illness

- Mild arthritis requiring NSAID medications

- Participants who have another cancer diagnosis, except that the following diagnoses

will be allowed:

- squamous cell cancer of the skin without known metastasis

- basal cell cancer of the skin without known metastasis

- carcinoma in situ of the breast (DCIS or LCIS)

- carcinoma in situ of the cervix

- any cancer without distant metastasis that has been treated successfully,

without evidence of recurrence or metastasis for over 5 years

- Participants with known addiction to alcohol or drugs who are actively taking those

agents, or participants with recent (within 1 year of registration) or ongoing illicit IV drug use.

- Body weight < 110 pounds (without clothes) at registration, due to the amount and

frequency with which blood will be drawn.

Locations and Contacts

Kristy Scott, BS, Phone: 434-982-6714, Email: ks4ww@virginia.edu

Cancer Center at the University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information

Starting date: June 2015
Last updated: April 20, 2015

Page last updated: August 20, 2015

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