Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT02833506 | Withdrawn Phase 1 DMC FDA Drug

• 4 other identifiers: I 277115NCI-2016-00811P30CA016056R01CA158318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I clinical trial studies the side effects of sirolimus and NY-ESO-1 protein with MIS416 in treating patients stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccine therapy, like Y-ESO-1 protein with MIS416, may strengthen the immune system to find and kill tumor cells. Biological therapies, such as sirolimus, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Giving sirolimus and vaccine therapy may work betting in treating patients with ovarian, fallopian tube or primary peritoneal cancer.

Conditions

Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Cancer; Stage IIC Fallopian Tube Cancer; Stage IIC Ovarian Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

  The toxicity rate for each adverse event will be estimated using a two-sided, 95%, exact binomial confidence interval (Clopper-Pearson).

  Up to 30 days

Secondary Outcomes (3)

• NY-ESO-1 specific CD4+ and CD8+ T-cells cellular immunity assessed in peripheral blood by enzyme-linked immunosorbent spot (ELISPOT) and intracellular cytokine staining (ICS)

  Up to 12 months

• NY-ESO-1 specific humoral immunity

  Up to 12 months

• Time to disease progression as documented by Response Evaluation Criteria in Solid Tumors version 1.1

  Up to 12 months

Study Arms (2)

Cohort I (NY-ESO-1 protein with MIS416)

ACTIVE COMPARATOR

Patients receive NY-ESO-1 protein with MIS416 vaccine SC on days 1, 15, 29, 57, 85, and 113 in the absence of disease progression or toxicity.

Other: Laboratory Biomarker Analysis; Biological: Recombinant NY-ESO-1 Protein

Cohort II (NY-ESO-1 protein with MIS416, sirolimus)

EXPERIMENTAL

Patients receive NY-ESO-1 protein with MIS416 vaccine as in Cohort I. Patients also receive sirolimus PO daily for 2 weeks followed by 2 weeks off starting on days 1, 29, 57, and 85.

Other: Laboratory Biomarker Analysis; Biological: Recombinant NY-ESO-1 Protein; Drug: Sirolimus

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Cohort I (NY-ESO-1 protein with MIS416); Cohort II (NY-ESO-1 protein with MIS416, sirolimus)

Recombinant NY-ESO-1 Protein BIOLOGICAL

Given recombinant NY-ESO-1 protein SC

Cohort I (NY-ESO-1 protein with MIS416); Cohort II (NY-ESO-1 protein with MIS416, sirolimus)

Sirolimus DRUG

Given PO

Also known as: AY 22989, RAPA, Rapamune, RAPAMYCIN, SILA 9268A, WY-090217

Cohort II (NY-ESO-1 protein with MIS416, sirolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have completed standard therapy for primary or recurrent disease (i.e., patients who would normally be observed); eligible patients may have asymptomatic residual measurable disease on physical examination and/or computed tomography (CT) scan, and/or may have an elevated cancer antigen 125 (CA-125); or may be in complete clinical remission after treatment for primary or recurrent disease; these patients would normally enter a period of observation after standard management
• Any human leukocyte antigen (HLA) type (historic HLA typing is permitted)
• Tumor expression of NY-ESO-1 by immunohistochemistry (IHC) and/or real-time polymerase chain reaction (RTPCR)
• No history of previous severe allergic reactions to vaccines or unknown allergens
• Life expectancy \> 6 months
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
• Absolute neutrophil count (ANC) \>= 1,000/uL
• Platelets (PLT) \>= 75,000/uL
• Hemoglobin (Hgb) \>= 8 g/dL
• Total bilirubin =\< 1.5 x upper limits of normal (ULN)
• Serum glutamic-oxaloacetic transaminase(SGOT)/aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase(SGPT)/alanine aminotransferase (ALT) =\< 3 x ULN
• Serum creatinine =\< 2 x ULN
• Prothrombin time(PT)/international normalized ratio(INR) =\< 1.5
• Electrocardiogram, showing no indications of cardiac problems like congestive heart failure, myocardial infarction, and cardiomyopathy

You may not qualify if:

• Metastatic disease to the central nervous system
• Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
• History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
• Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal antiinflammatory drugs for \>2 weeks,, and other platelet inhibitory agents, strong inhibitors/inducers of cytochrome P450-3A4 (CYP450-3A4)
• Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
• Patients with a positive fecal occult blood test excluding hemorrhoids
• Clinically significant heart disease (New York Heart Association \[NYHA\] class III or IV) within six months
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
• Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
• Lack of availability of a patient for immunological and clinical follow-up assessment
• Known pulmonary hypertension
• Known hypersensitivity to sirolimus
• Evidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigator's opinion will prevent completion of the protocol therapy or follow-up
• Pregnant or nursing female patients

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Kunle Odunsi

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 14, 2016
• Study Start: December 8, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

US (1)