Study of IMF-001 in Patients With Malignancies Expressing NY-ESO-1

NCT01234012 | Completed Phase 1

• 1 other identifier: IMF001-PRT001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is assess the safety of administering repeated doses of IMF-001, a vaccine, to patients with solid tumors that express NY-ESO-1 antigen. If the vaccine is therapeutically useful, a second goal is to establish the maximum therapeutic dose to treat patients with NY-ESO-1 positive cancers.

Conditions

Solid Tumor

Keywords

melanoma; breast cancer; ovarian cancer; prostate cancer; esophageal cancer; uterine cancer; sarcoma; NY-ESO-1

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events as a measure of safety and tolerability of repeat doses.

  Date of first dose until 30 days after off-study, or until resolution of related AEs

Secondary Outcomes (3)

• Tumor response using RECIST 1.1

  Each cycle at weeks 7 and 11 (appx.)

• Humoral and cellular immune response as indication of IMF-001 biologic activity

  Starting from first dose, samples taken within 72hrs of the 1st, 3rd, and 5th doses of each cycle until off-study

• Optimal dose based on number of patients with adverse events at that dose

  Date of first dose until 30 days after off-study, or until resolution of related AEs

Study Arms (1)

Treatment: IMF-001

EXPERIMENTAL

100 or 200 mcg will be administered to patients subcutaneously every 2 weeks for 6 injections.

Biological: IMF-001

Interventions

IMF-001 BIOLOGICAL

subcutaneous injection of fixed dose IMF-001 (100 or 200 mcg) every 2 weeks.

Treatment: IMF-001

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven progressive or metastatic solid tumors expressing NY-ESO-1, who have failed standard treatment and have no other effective treatment available (solid tumors such as melanoma, breast cancer, ovarian cancer, prostate cancer, esophageal cancer, uterine cancer, and sarcoma frequently express NY-ESO-1). Patients with malignant melanoma stages IIb and III, or stage IV melanoma that has been completely resected, or with stage I and II uterine serous cancer, clear cell carcinoma, or carcinosarcoma with documented expression of NY-ESO-1 may also enroll as they have a 50% or greater chance of developing recurrent disease.
• Documentation of tumor cells expressing NY-ESO-1 antigen as determined by immunohistochemistry.
• Must have target lesion(s) measurable or non-measurable by RECIST version 1.1. Exceptions: Patients with stages IIb or III melanoma, or stage IV melanoma that has been completely resected, will have no target lesions measurable by RECIST version 1.1 but may enroll; patients with prostate cancer without measurable disease but with rising prostate specific antigen (PSA) levels may enroll; patients with resected stage I and II uterine serous cancer, clear cell carcinoma, and carcinosarcoma will have no target lesions measurable by RECIST but may enroll.
• Has recovered from all acute adverse effects of prior therapy, with the exception of alopecia.
• Laboratory values within the following limits:
• Hemoglobin ≥ 8.0 g/dL
• WBC count ≥ 2.0 x 10\^9/L
• ANC ≥ 1.0 x 10\^9/L
• Platelet count ≥ 75 x 10\^9/L
• Serum creatinine ≤ 1.5 mg/dL
• AST \& ALT ≤ 2.5 x ULN (≤ 5 x ULN if with hepatic metastases)
• Serum total bilirubin ≤ 1.5 x ULN
• Performance status of 0 or 1 (ECOG Scale).
• Life expectancy ≥ 4 months.
• Ages 18 years or over.

You may not qualify if:

• Clinically significant heart disease (NYHA Class III or IV).
• Serious active infection requiring antibiotics.
• Bleeding disorders.
• Unstable metastatic disease in the central nervous system.
• Concomitant systemic treatment with corticosteroids. Topical steroids are permitted.
• History of any severe or life-threatening hypersensitivity or allergic reaction.
• Known HIV infection.
• History of immunodeficiency disease or autoimmune disease, including scleroderma, Sjögren's syndrome, lupus erythematosus, idiopathic thrombocytopenic purpura (ITP), multiple sclerosis, or rheumatoid arthritis.
• Has received anticancer chemotherapy, immunotherapy, radiotherapy or any other investigational agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to enrollment. Concomitant immunosuppressive therapy is not permitted. Adjuvant interferon alpha is not allowed for patients with stages IIb, III or IV melanoma. Prostate cancer patients with PSA only recurrence may have had previous androgen deprivation therapy, provided the 4 week washout period is observed.
• Pregnant or lactating women.

Sponsors & Collaborators

• ImmunoFrontier, Inc.: lead

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

New York University (NYU) Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanoma; Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms; Esophageal Neoplasms; Uterine Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Uterine Diseases; Neoplasms, Connective and Soft Tissue

Study Officials

• DAIJU ICHIMARU, BS

  ImmunoFrontier, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: November 4, 2010
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

US (2)