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MelanomaPhase 1NCT01008527

Phase I Oncovir Poly IC:LC and NY-ESO-1/gp100

A Phase 1 study testing CP 870,893, Peptides and Oncovir poly IC:LC in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patients before, and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
CP 870,893, Peptides and Oncovir poly IC:LC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Oct 2009to Sep 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet the following criteria on pre-study examination (within 28 days prior to study drug administration) to be eligible to participate in the study:
  • Have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
  • Histologic diagnosis of Stage III (with ≥ 3 positive lymph nodes) or Stage IV melanoma that has been resected completely (may include mucosal or ocular melanoma) no more than 6 months prior to screening
  • Human leukocyte antigen (HLA)-A*0201 status as determined by deoxyribonucleic acid (DNA) allele-specific polymerase chain reaction (PCR) assay
  • Positive staining of tumor tissue with at least one of the following: antibody HMB-45 for gplOO, NY-ESO-l, or MART-I
  • At least 4 weeks since treatment (surgery, chemotherapy, immunotherapy, radiotherapy) and at least 6 weeks for treatment with nitrosoureas for melanoma, and at least 8 weeks since adjuvant treatment with an anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody for melanoma and recovered from any serious toxicity experienced during treatment
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  • Women must be either: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception during the study and for at least 4 months after the final CP 870,893 infusion or vaccination. Women of childbearing potential must have a negative serum hCG- ß pregnancy test conducted during the screening period and have a negative urine pregnancy test conducted on the day of each infusion (prior to the infusion).
  • Men who may father a child must agree to the use of male contraception for the duration of their participation in the trial and for at least 4 months after the final CP 870,893 infusion or vaccination.
  • Patients with Stage III resected melanoma rendered free of disease can have failed treatment with, been ineligible for, or refused treatment with a-interferon.
  • Analgesic therapy must be stable for a period of 14 days prior to infusion of study drug.
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients with resected brain metastases that are off steroids, have no evidence of disease by brain magnetic resonance imaging (MRI) scanning, or computer tomography (CT) of the brain if an MRI cannot be performed, are eligible.
  • Screening laboratory values must meet the following criteria: white blood cell (WBC): ≥2500 cells/mm³; absolute neutrophil count (ANC): ≥1500 cells/mm³, Platelets: ≥100,000/mm³; Hematocrit: ≥30%; Hemoglobin: ≥10 g/dL; Creatinine: ≤2.0 mg/dL; aspartate aminotransferase (AST): ≤3 x ULN; Bilirubin: ≤1.0 x upper limit of normal (ULN) (except patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dL); human immunodeficiency virus (HIV): negative; HBsAg: negative; hepatitis C virus (HCV) antibody [anti-HCV Ab]: nonreactive. If reactive, patient must have a negative HCV RNA qualitative PCR.

Who cannot join

  • Any prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or any other cancer from which the patient has been disease-free for at least 5 years.
  • History of any autoimmune disease, specifically including the following diseases: inflammatory bowel disease or any other autoimmune bowel diseases; systemic lupus erythematosis; rheumatoid arthritis; or any autoimmune ocular diseases. Patients with an autoimmune disease history affecting the pancreas, pituitary, liver, gastrointestinal (GI) tract or adrenals, and prior history of Guillan-Barre and other neurologic conditions felt to be autoimmune in nature are also excluded.
  • Active infection, requiring therapy, chronic active hepatitis B virus (HBV) or HCV, or confirmed reactivity with HIV tests.
  • Pregnancy or nursing: due to the possibility that CP 870,893 could have a detrimental effect on the developing immune system of the fetus or infant, exposure in utero or via breast milk will not be allowed.
  • Systemic hypersensitivity to Montanide ISA 51 (IFA), Montanide ISA 51 VG or any vaccine component
  • Any underlying medical condition which, in the opinion of the Principal Investigator (PI), will make the administration of study drug hazardous or obscure the interpretation of adverse events.
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  • Any concurrent medical condition requiring the use of systemic, inhaled or topical corticosteroids or the use of immunosuppressive agents (e.g. cyclosporine and its analog, or chemotherapy agents). All corticosteroid use must have been discontinued at least 4 weeks prior to study entry.
  • Prior treatment with CP 870,893 or any anti-CD40 antibody
  • Evidence or history of significant cardiac, pulmonary, hepatic, renal, psychiatric or gastrointestinal disease that would make the administration of CP 870,893 unsafe
  • Concurrent treatment with chemotherapy or other immunotherapy regimens (must be completed at least 4 weeks before Screening; 6 weeks for nitrosoureas); prior treatment with chemotherapy, radiotherapy or other than anti CD40 antibodies will not be an exclusion.
  • History of prior allogeneic human stem cell or bone marrow transplant
  • History of prior thromboembolic venous events, or inherited / acquired coagulopathies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I Study of Poly IC:LC and NY-ESO-1/gp100 Peptides Either Emulsified With Montanide ISA 51 or in Aqueous Solution With Escalating Doses of CP 870,893 in the Treatment of Subjects With Resected Stage III or Stage IV Melanoma

The purpose of this study is to determine what side effects CP 870,893 may cause when given with an immune stimulant called Oncovir poly IC:LC along with a melanoma vaccine. The CP 870,893, the Oncovir poly IC:LC and the melanoma vaccine are investigational drugs that have not been combined in patients before, and that have not been approved for sale by the Food and Drug Administration. The Oncovir poly IC:LC is intended to stimulate the body's immune system.

Read the detailed description

Antibodies such as CP 870,893 are chemicals made by immune cells naturally found in the human body. CP 870,893 was produced in cells grown from a hamster but is fully human in composition. The vaccine contains peptides (pieces) from two different proteins called NY-ESO-1 and gp100. Each one is made by 50-100% of melanomas. These proteins can be recognized by the immune system. They will be injected under the skin of the participant's thigh in combination with, or without an oil-based substance, called "Montanide ISA 51 VG". The Montanide ISA 51 VG is an adjuvant or "assistant" which stimulates the body's immune system. The peptides in the vaccine, the Montanide ISA 51 VG, the Oncovir poly IC:LC and the CP 870,893 antibody are not approved by the Food and Drug Administration (FDA) but the FDA is permitting their use in this study. It is believed that the CP 870,893 and the Oncovir poly IC:LC will boost the body's immune response against the melanoma vaccine, although this vaccine has not been proven to help the patient's melanoma.

Conditions
Melanoma
Being tested
CP 870,893, Peptides, Oncovir poly IC:LC
Keywords
skin, cutaneous, immunotherapy, immunology, dose escalation
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CP 870,893Drug

    Also called NSC 750268

    Study drug will be administered open-label as an intravenous solution, followed by observation. Study drug will be supplied as a liquid intravenous solution in vials containing 10 mg/mL of CP870,893. CP 870,893 will be administered at a dosage of 0.01, 0.025 or 0.05 mg/kg at 0.24 mg/mL infused via a syringe pump over 15 minutes, or at 0.1 or 0.2 mg/kg/dose as an i.v. infusion in saline at a concentration of 0.24 mg/mL in an IV bag of up to 100 mL over 30 minutes (controlled by a volumetric pump) for not more than 30 minutes, with a 10 cc flush at the end that should be administered at the same rate as the CP 879,893 infusion.

  • PeptidesBiological

    Also called NSC 717388, NSC 683473, NSC 737063

    NY-ESO-l 157-165 (165V) and gpl002 80-288 (288V) peptides each at a dose of 0.5 mg will be emulsified with Montanide ISA 51 VG and administered to all patients in the study at Weeks 1,3, 5, 7, 9, 11, 17, 21, 25 33, 41, and 53. Peptides will be administered as a total of 6 deep subcutaneous (s.c.) injections into alternating lower extremities one hour after CP 870,893 infusions.

  • Oncovir poly IC:LCBiological

    Also called Hiltonol, NSC 301463

    The dosage of poly IC:LC chosen for the current trials has been used safely in over one hundred patients with central nervous system (CNS) malignancies enrolled in nitrates and bone turnover (NABT) trials. The injection of 1000 mcg will be made deeply subcutaneously into the same limb as the peptides/Montanide ISA 51 VG, at least 5 cm. proximal to the peptides vaccination site. Poly IC:LC will be administered to all patients in the study at Weeks 1, 3, 5, 7, 9, 11, 17, 21, 25 33, 41, and 53 one hour after CP 870,893 infusion.

Study groups in NCT01008527
Study groupRoleWhat they receive
Infusion and Peptide AdministrationExperimentalPatients get the study drug Oncovir poly IC:LC with or without CP 870-893. Up to 6 groups of 3 to 10 patients each will be treated in this study. The first group (between 3 and 6 patients) gets peptide vaccine with poly IC:LC. Second, third and fourth groups of 3 to 6 patients receive peptide vaccine with poly IC:LC and the antibody CP 870,893 at increasing doses from 0.01, 0.025 and 0.05 mg/kg. CP 870-893 will be given to 10 patients at a dose of 0.1 mg/kg to patients in the fifth group, and 0.2 mg/kg to the sixth group. The CP 870,893 will be given as an intravenous infusion over 30 minutes and will be given once every 2 weeks for the first 6 infusions. CP-870-893 will then be given every 4 to 6 weeks for 3 injections. The final 3 injections of CP 870,893 will be given every 8 to 12 weeks. These infusions will take place on weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53 for a total of 12 infusions.
Receives: Drug: CP 870,893; Biological: Peptides; Biological: Oncovir poly IC:LC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    The overall goal is to define a safe and potentially effective dose and schedule of CP 870,893 with Oncovir poly IC:LC with a peptide vaccine with either Montanide ISA 51 VG or in aqueous solution for the adjuvant setting in high risk melanoma.

    Measured: 3 Years

Secondary outcomes (2)

  1. Number of Participants With Immunologic Response

    To assess immune responses to the study regimens.

    Measured: 3 Years or until relapse

  2. Number of Participants With Progression Free Survival (PFS)

    Relapse free survival will be summarized in a standard exploratory fashion via descriptive summary statistics by dose.

    Measured: 3 Years or until relapse

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionSep 2013
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008527
Sponsor's protocol ID
MCC-15383
Other IDs
106566, NCI-P-8215
Status last verified
Sep 2015
First submitted
2 Nov 2009
Last updated
24 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CP 870,893, Peptides and Oncovir poly IC:LC in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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