This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Boston Biomedical, Inc
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc
ClinicalTrials.gov Identifier:
NCT02498665
First received: July 13, 2015
Last updated: December 21, 2016
Last verified: December 2016
  Purpose
This is a multicenter, open label, Phase 1 dose-escalation study of DSP-7888 Dosing Emulsion administered to adult patients with advanced malignancies. Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase.

Condition Intervention Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Glioblastoma Multiforme Melanoma Non-Small Cell Lung Cancer Ovarian Cancer Pancreatic Cancer Sarcoma Renal Cell Carcinoma Drug: DSP-7888 Dosing Emulsion Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by Boston Biomedical, Inc:

Primary Outcome Measures:
  • Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]
  • Determination of the safety and tolerability of DSP-7888 Dosing Emulsion by assessing duration of study treatment [ Time Frame: 12 months ]
  • Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Assessment of the preliminary anti-tumor activity by assessing Progression-Free Survival (solid tumors and acute myeloid leukemia (AML)) [ Time Frame: 12 months ]
    Evaluation of anti-tumor activity will be performed according to Immune Related Response Criteria (irRC) for solid tumors. For patients with ovarian cancer who have disease at baseline that is evaluable by CA-125 criteria only, the Gynecologic Cancer Intergroup (GCIG) criteria will be used for response assessment. For patients with AML, response assessment will be performed according to the AML International Working Group (IWG) criteria.

  • Overall Survival [ Time Frame: 12 months ]
  • Pharmacodynamic activity of DSP-7888 Dosing Emulsion as assessed by biomarker analysis [ Time Frame: 12 months ]
    Cytotoxic T lymphocyte induction, histopathology and Reverse transcription polymerase chain reaction (RT-PCR) assays will be performed to provide information of the biomarkers on biopsied patient tumor tissue, archival samples and peripheral blood samples.


Estimated Enrollment: 76
Study Start Date: November 2015
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DSP-7888 Dosing Emulsion
Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously. Dose-escalation will proceed according to the Criteria for Dose Escalation and Criteria for Determination of Dose-Limiting Toxicity (DLT) as indicated below. Dose Level I: 3.5 mg, Dose Level II: 10.5 mg, Dose Level III: 17.5 mg
Drug: DSP-7888 Dosing Emulsion
Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) and local regulatory requirements
  2. Patient has one of the following histologically or cytologically confirmed advanced malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), glioblastoma multiforme (GBM), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, sarcoma, renal cell carcinoma (RCC)
  3. Patient must meet at least one of the following criteria: a. Progressed or recurrent despite standard therapy, b. No standard therapy exists for this malignancy, c. Patient is intolerant of standard therapy, d. Patient is not a candidate for standard therapy, e. For AML and MDS patients: patient is not a candidate for allogeneic hematopoietic stem cell transplantation, f, For sarcoma patients: f-1. Patient has disease that is metastatic or unresectable, f-2. Patient with metastatic disease has had at least one prior line of therapy for metastatic disease, f-3. No curative multimodality options exist
  4. Patients must be positive for at least one of the following human leukocyte antigens (HLA): a. HLA-A*02:01, b. HLA-A*02:06, c. HLA-A*24:02
  5. ≥ 18 years of age
  6. For patients with solid tumors, one of the following must apply: a. Patient has measurable disease as defined by the immune-related response criteria (irRC), b. Patient has ovarian cancer and has disease evaluable by CA-125 only
  7. For patients with solid tumors, the following criteria apply: a. Hemoglobin ≥ 9.0 g/dl, b. Absolute lymphocyte count ≥ 1.0 x 10^9/L, c. Absolute neutrophil count ≥ 1.5 x 10^9/L, d. Platelets ≥ 100.0 x 10^9/L
  8. Patients with MDS must have been diagnosed as MDS by WHO (4th edition) or French-American-British (FAB) classification
  9. Patients with MDS must meet one of the following International Prognostic Scoring System (IPSS) criteria: a. IPSS score is ≥ 1.5, b. IPSS score is < 1.5 but patient's condition remains uncontrolled on supportive therapy alone, in the opinion of the investigator
  10. For patients with AML or MDS, patient must have white blood cell count (WBC) ≤ 50,000/mL. Hydroxyurea is allowed to achieve this change but must be discontinued a minimum of five (5) days prior to baseline evaluation
  11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  12. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 180 days after the DSP-7888 Dosing Emulsion dose
  13. Females of childbearing potential must have a negative serum pregnancy test
  14. Total bilirubin of ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome)
  15. Aspartate Aminotransferase (AST) ≤ 3.0x the upper limit of normal (ULN)
  16. Alanine transaminase (ALT) < 3.0x the upper limit of normal (ULN)
  17. Creatinine ≤ 2.0x ULN
  18. Life expectancy ≥ 3 months
  19. For patients with solid tumors, either archival tumor tissue must be available or patient must consent to undergo on-study tumor biopsy before administration of first dose

Exclusion Criteria:

  1. Patient has an extensively disseminated primary glioblastoma
  2. Patient has acute promyelocytic leukemia (APML)
  3. For AML and MDS patients: patients with a dry tap on bone marrow aspiration during screening
  4. Patient has symptomatic brain metastases (i.e., metastases that are accompanied by neurological symptoms or that require treatment with corticosteroids)
  5. Patient has an infection requiring treatment with systemic antibiotics or antiviral medication or has completed treatment for such an infection within 14 days prior to planned first dose of study drug
  6. Patient requires systemic, pharmacologic doses of corticosteroids (equivalent to >30 mg hydrocortisone/day) Note: Replacement doses (equivalent to ≤ 5 mg prednisone/day), and topical, ophthalmic, and inhalation steroids are permitted as needed
  7. Patient has a positive test for Hepatitis B surface antigen, Hepatitis C antibody, human immunodeficiency virus HIV-1 or HIV-2 antibody, or has a history of a positive result for hepatitis C virus (HCV) or HIV
  8. Patient has received any of the following treatments within the specified timeframes: a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): 4 weeks (28 days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): 4 weeks (28 days), c. Endocrine therapy or immunotherapy (including biological response modifier therapy): 2 weeks (14 days)
  9. Patient has an unresolved ≥ Grade 2 adverse event (AE) from a previous antineoplastic treatment, excluding alopecia and phlebitis
  10. Patient has had surgery within 4 weeks prior to first dose
  11. Woman who is pregnant or lactating or has a positive pregnancy test at screening. If a woman has a positive pregnancy test, further evaluation may be conducted to rule out ongoing pregnancy to allow the patient to be eligible
  12. Patient has any concurrent autoimmune disease or has a history of chronic or recurrent autoimmune disease; these include but are not limited to: multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura
  13. Patient has, in the opinion of the treating investigator, any intercurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results; these conditions include, but not limited to: congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina, cardiac arrhythmia requiring treatment, recent (within the prior 6 months) myocardial infarction, acute coronary syndrome or stroke, severe obstructive pulmonary disease, hypertension requiring more than 2 medications for adequate control, or diabetes mellitus with more than 2 episodes of ketoacidosis in the prior 12 months
  14. Patient has Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 grade ≥ 2 hemorrhage
  15. Patient has pleural effusion, ascites, or pericardial fluid requiring drainage Note: Patient who had drain removal ≥ 14 days prior to planned first dose of study drug and has no sign of worsening is eligible
  16. Patient has any other medical, psychiatric, or social condition, including substance abuse, that in the opinion of the investigator would preclude compliance with the requirements of this study
  17. Patients with two or more active malignancies (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ≤ 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been curatively treated with local therapy)
  18. Patient has had previous treatment with the study drug or other Wilms' tumor 1 (WT1)-related immune therapy
  19. Patient has history of allergy to any oily drug products
  20. Patient has a known hypersensitivity to any of the components of the study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02498665

Contacts
Contact: Boston Biomedical 855-689-4455

Locations
United States, Colorado
Usor - Rmcc Recruiting
Denver, Colorado, United States, 80218
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Emma Judson, PhD    404-778-2695    ejudson@emory.edu   
United States, Texas
USOR - TX Oncology Austin Recruiting
Austin, Texas, United States, 78705
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
USOR -TX Oncology Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
USOR - TX Oncology Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
United States, Virginia
USOR - VA Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
USOR - VA Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Crystal Kohn (Speaks), MPH    281-863-4697    Crystal.Speaks@mckesson.com   
Sponsors and Collaborators
Boston Biomedical, Inc
  More Information

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT02498665     History of Changes
Other Study ID Numbers: BBI-DSP7888-101
Study First Received: July 13, 2015
Last Updated: December 21, 2016

Keywords provided by Boston Biomedical, Inc:
Wilms' Tumor 1
Vaccine
Neoplasms

Additional relevant MeSH terms:
Glioblastoma
Carcinoma, Non-Small-Cell Lung
Leukemia, Myeloid, Acute
Pancreatic Neoplasms
Myelodysplastic Syndromes
Preleukemia
Carcinoma, Renal Cell
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Astrocytoma
Glioma
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on August 23, 2017