Vaccine Therapy in Treating Patients With Metastatic Solid Tumors

STATUS

Recruiting
End date

Dec 31, 2022
participants needed

100
sponsor

Pravin Kaumaya

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Updated on 3 November 2021

See if I qualify

platelet count

cancer

monoclonal antibodies

growth factor

endocrine therapy

serum bilirubin

metastasis

hormone therapy

tumor cells

epidermal growth factor receptor

EGFR

vaccine therapy

neuropathy

cancer chemotherapy

solid tumour

erbb2

epidermal growth factor

mammogram

Summary

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.

Description

PRIMARY OBJECTIVES:

I. To perform early phase clinical trial assessing safety and clinical toxicity of immunization, and as well as to establish an optimal biological dose (OBD) of combination vaccines with n-muramyldipeptide derivative (nor-MDP) as adjuvant emulsified in Montanide (ISA 720).

II. To establish whether an OBD of two combination vaccines is achieved. III. To measure both humoral and cellular immune responses including the specificity, class and kinetics of anti-human epidermal growth factor receptor-2 (HER-2) peptide.

IV. To evaluate whether the combination of HER-2 epitopes show therapeutic benefit, provide synergistic and/or additive effects and to enumerate mechanisms of action.

SECONDARY OBJECTIVES:

I. To collect and analyze post-immune sera and peripheral blood cells for additional six months post the last injection.

II. To document any clinical responses that may occur.

OUTLINE: This is a dose-escalation study.

Patients receive a HER2/neu peptide vaccine comprising measles virus epitope MVF-HER-2 (266-296) and MVF-HER-2 (597-626) emulsified with nor-MDP in ISA 720 intramuscularly (IM) on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

OUTLINE: EXTENSION TRIAL AT OBD

The dose-escalation (4 cohorts) has successfully completed with the accrual of 24 patients and the Optimum biological dose (OBD) has been determined as the dose at cohort level 2.

The next phase of the study progresses directly into an extension trial at the OBD. 12 patients will be accrued at that level. The extension cohort will be open to only HER-2 and/or EGFR overexpressing cancers. Patients (all gastrointestinal,ovarian and breast must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients (breast, ovarian and gastrointestinal cancers) must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.

Details

Condition	Ovarian Function, cancer, breast, cancer, ovarian, Ovarian disorder, ovarian carcinomas, cancer ovarian, gist, Breast Cancer Diagnosis, Malignant neoplasm of colon, Ovarian Cancer, gastrointestinal stromal tumors, gastrointestinal stromal tumor, Malignant Solid Tumour, cancer of the ovary, Malignant Solid Tumor, Colon Cancer, breast carcinoma, Recurrent Ovarian Cancer, Breast Cancer, Malignant Solid Neoplasm, ovarian tumors
Treatment	HER-2 vaccine, Extension HER-2 vaccine trial at OBD
Clinical Study Identifier	NCT01376505
Sponsor	Pravin Kaumaya
Last Modified on	3 November 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Must have histologically confirmed metastatic solid tumor; the malignancy should be considered incurable using standard treatment
	Patients are not required to have HER-2 over-expression to be on this study
	If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted
	If the patient has not had HER-2 expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of HER-2 expression
	Patients are not required to have epidermal growth factor receptor (EGFR) over-expression to be on this study
	If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted
	If the patient has not had EGFR expression measured prior to enrollment on this study tumor tissue blocks and/or freshly isolated tissue must be available for determination of EGFR expression
	Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible
	Patients must be ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
	White blood cells > 3500/mm^3
	Platelet count > 100,000/mm^3
	Serum bilirubin < 1.5 mg %, regardless of whether patients have liver involvement secondary to tumor
	Alanine aminotransferase (ALT) must be < 2 times upper limit of normal
	Creatinine < 1.5 mg/dL or calculated creatinine clearance > 60 mL/min
	Patients will be tested for reactivity to a panel of four common microbial skin test antigens: candida, trichophyton, intermediate strength purified protein derivative (PPD), and tetanus toxoid; determination of patient eligibility for this trial will proceed independently of these skin test results; patients who have previously been tested for these antigens but were excluded from participation in the trial due to non-reactivity may be considered as eligible provided that all other eligibility criteria are met
	Patients must be at least 4 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy; patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent); patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2
	Women of child-bearing potential must not be pregnant and must have a negative pregnancy test; men and women must agree to practice effective contraception while on this study
	Patients must obtain a base line Echocardiogram or multi gated acquisition scan (MUGA) and require the left ventricular ejection fraction to be within normal limits (or 50% or higher)
	Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Exclusion Criteria
	Patients with ICH of 0
	Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4/6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy
	Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive
	Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection; if patient develops an infection requiring antibiotic treatment while on the treatment portion of the study patients will be treated for the active infection with antibiotics and will resume vaccine treatment when the infection is healed
	Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection
	Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases
	Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
	Splenectomized patients
	Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome
	Patients who have developed anaphylactic responses to other vaccines
	History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention
	ADDITIONAL KEY ELIGIBILITY CRITERIA FOR EXTENSION & EXPANSION COHORT
	Histologically documented metastatic or unresectable breast, ovarian and gastrointestinal cancers
	Progressive disease after at least one line of standard therapy
	Patients must have received or refused first line standard systemic therapy for their metastases (if applicable)
	Patients (pancreatic and esophageal cancers) must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients (breast and gastrointestinal cancers) must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy
	Measurable disease, defined as 1 lesions that can be accurately measured in 1 dimensions as 20 mm with conventional techniques or as 10 mm with spiral CT scan
	Disease that is amenable to biopsy and be willing to undergo tumor biopsy

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Vaccine Therapy in Treating Patients With Metastatic Solid Tumors