A Phase I Safety Study of a Cancer Vaccine to Treat HLA-A2 Positive Advanced Stage Ovarian, Breast and Prostate Cancer

NCT01095848 | Completed Phase 1 DMC

• 1 other identifier: ONC-DPX-0907-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

To determine the safety and immunogenicity profile of two (2) different doses of the vaccine DPX-0907 to treat breast, ovarian and prostate cancer.

Conditions

Ovarian Neoplasms; Breast Neoplasms; Prostatic Neoplasms

Keywords

vaccine; cancer; ovarian; breast; prostate; tumor; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• To determine the safety profile of two different doses of subcutaneously administered DPX-0907. Safety assessments will be based on reported adverse events and the results of vital sign measurements, physical examinations, and clinical laboratory tests.

  On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period

Secondary Outcomes (2)

• To determine the levels of CMI (cell mediated immunity) to the 7 cancer epitopes induced by vaccination with DPX-0907

  On each vaccination day, 30 days after last vaccination

• To establish a recommended dose based on safety and immune response for phase 2 studies.

  On each vaccination day, 30 days after last vaccination and every month during the 6 month follow-up period

Study Arms (2)

0.25ml dose DPX-0907

EXPERIMENTAL

On each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion.

Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG

1ml dose DPX-0907

EXPERIMENTAL

On each vaccination day the lyophilized antigen/adjuvant/liposome complex is re-suspended in the oil (Montanide 1SA51 VG) before injection. The vaccine is not an emulsion.

Biological: DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG

Interventions

DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG BIOLOGICAL

Patients will receive three deep subcutaneous injections of the vaccine three weeks apart in the upper thigh region. Patients will be followed for up to 7 months.

0.25ml dose DPX-0907; 1ml dose DPX-0907

Eligibility Criteria

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

You may qualify if:

• Patients with stage III or IV ovarian cancer who have completed a course of platinin-based cytotoxic therapy after debulking surgery with evidence of a complete or partial response by radiological imaging. Patients with metastatic ovarian cancer who have stable disease for greater than 3 months after completion of first-line therapy.
• Patients with stage IV breast cancer who have received at least 1 course of hormonal or cytotoxic therapy for metastatic cancer. Patients must be off cytotoxic therapy with stable disease or better for 3 months or greater duration. Patients may have stable disease and still be on hormonal therapy.
• Patients with prostate cancer who have failed at least 1 course of an accepted hormonal therapy. Specifically prostate cancer patients must have castrate testosterone levels (\< 50 ng/dl) and 2 PSA values higher than the previously documented baseline at least 3 weeks apart or evidence of increases in measurable disease. These patients may have received previous courses of cytotoxic chemotherapy although chemotherapy naïve patients who are deemed not good candidates or who have refused cytotoxic therapy will be eligible. These patients may remain on anti-androgen therapy during the trial. Patients with evidence of progressive bone or other metastases are acceptable.
• At least 8 weeks since previous courses of an investigational biologic therapy (i.e. cancer vaccine) including active or passive immunotherapy.
• At least 30 days since localized surgery or radiotherapy.
• At least 30 days since initiation of a biphosphonate treatment.
• HLA A2 haplotype.

You may not qualify if:

• History of autoimmune disease, such as inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with a remote history (greater than five years) of thyroiditis are not excluded.
• Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection such as: urinary tract infection, HIV, or antigen positive viral hepatitis.
• Previously resected brain metastases unless a CT or MRI scan of the brain shows no metastasis within 1 month of receiving DPX-0907.
• Concurrent (within the last 5 years) second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer.
• Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions.
• Serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV) or hepatic disease.
• Steroid therapy or other immunosuppressives, such as azathioprine or cyclosporin A, unless steroids are discontinued 6 weeks prior to study.
• Allergies to any component of the vaccine.
• Inability to gain venous access.
• Previous splenectomy.
• Previous lymphadenectomy in both inguinal regions.
• Pregnant or nursing mothers.
• Medical or psychological impediment or active drug or alcohol use that might preclude protocol compliance.

Sponsors & Collaborators

• ImmunoVaccine Technologies, Inc. (IMV Inc.): lead

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612-3244, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

Related Publications (1)

• Berinstein NL, Karkada M, Morse MA, Nemunaitis JJ, Chatta G, Kaufman H, Odunsi K, Nigam R, Sammatur L, MacDonald LD, Weir GM, Stanford MM, Mansour M. First-in-man application of a novel therapeutic cancer vaccine formulation with the capacity to induce multi-functional T cell responses in ovarian, breast and prostate cancer patients. J Transl Med. 2012 Aug 3;10:156. doi: 10.1186/1479-5876-10-156.

  PMID: 22862954 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; 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; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Morse, MD

  Duke University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (5)