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Trial record 45 of 77 for:    cancer IL-15

QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel

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ClinicalTrials.gov Identifier: NCT02559674
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Altor BioScience

Brief Summary:
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Cancer Biological: Gemcitabine Biological: Nab-paclitaxel Biological: ALT-803 Phase 1

Detailed Description:

The purpose of this study is to evaluate the safety and tolerability of escalating doses, to identify the Maximum Tolerated Dose (MTD) and designate a dose level for Phase II study (RP2D) of ALT-803 administered in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.

To access the anti-tumor activity of ALT-803 administered in combination with gemcitabine and nab-paclitaxel as measured by objective response rate, overall survival, progression-free survival, time to progression, and duration of response in patients with advanced pancreatic cancer.

To Characterize the pharmacokinetic, immunogenicity, and serum cytokine profile of ALT-803 in combination with gemcitabine and nab-paclitaxel in treated patients. To correlate circulating cell free DNA and circulating tumor DNA with clinical outcomes of the study in treated patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel Biological: Gemcitabine
Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of gemcitabine given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
Other Name: Gemzar

Biological: Nab-paclitaxel
Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of nab-paclitaxel given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
Other Name: Abraxane

Biological: ALT-803
Subcutaneous Injection; Patients will receive two 4-week cycles consisting of ALT-803 given on Day 2, 9, 16, 30, 37, and 44. Eligible patients may receive up to 10 additional treatment cycles.




Primary Outcome Measures :
  1. Determination of MTD; Phase Ib [ Time Frame: 9 Months ]
    Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II.

  2. Safety Profile (Number and severity of treatment related AEs); Phase Ib and II [ Time Frame: 48 Months ]
    Number and severity of treatment related adverse events (AEs) that occur or worsen after the first dose of study treatment

  3. Overall Survival; Phase II [ Time Frame: 8.5 Months ]
    Determine the 8.5 month overall survival of treated patients


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 72 Months ]
    Evaluate objective response rate in treated patients.

  2. Duration of response [ Time Frame: 72 Months ]
    Evaluate duration of response in treated patients.

  3. Time to progression [ Time Frame: 72 Months ]
    Evaluate time to progression in treated patients.

  4. Progression-free survival [ Time Frame: 72 Months ]
    Evaluate progression-free survival in treated patients.

  5. Biomarkers; Phase Ib [ Time Frame: 36 Months ]
    Measure the serum levels of the following including but not limited to Interleukin-2 (IL-2), Interleukin-4 (IL-4), Interleukin-6 (IL-6), Interleukin-10 (IL-10), Interferon-gamma (IFN-ɣ), Tumor necrosis factor-alpha (TNF-α) and Monocyte chemoattractant protein-1 (MCP-1)

  6. Determine the level of anti-ALT-803 antibodies in patient serum [ Time Frame: 36 Months ]
    Determine the level of anti-ALT-803 antibodies in patient serum

  7. Area under the plasma concentration-time curve from time zero to infinity (AUC); Phase Ib [ Time Frame: 36 Months ]
    Area under the plasma concentration-time curve from time zero to infinity (AUC)

  8. Correlation between the level of circulating cell free DNA in patient plasma and response to study treatment [ Time Frame: 36 Months ]
    Correlation between the level of circulating cell free DNA in patient plasma and response to study treatment

  9. Correlation between the level of tumor DNA in patient plasma and response to study treatment [ Time Frame: 36 Months ]
    Correlation between the level of tumor DNA in patient plasma and response to study treatment



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

DISEASE CHARACTERISTICS:

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of pancreatic cancer.

    • For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection.
    • For expansion phase (Phase II) distant metastatic disease only.
  • For dose escalation phase (Phase Ib) 0 or 1 prior lines of chemotherapy for advanced pancreatic cancer. Prior gemcitabine is allowed, however prior nab-paclitaxel is not allowed.
  • For expansion phase (Phase II) no prior therapy for pancreatic cancer is allowed except for adjuvant therapy as long as it was completed ≥ 6 months prior to study treatment start
  • Have at least one untreated and progressing tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor
  • Prior radiation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Radiation therapy must have been completed at least 4 weeks prior to the baseline scan
  • Resolved acute effects of any prior therapy to baseline or Grade ≤1
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
  • Life expectancy ≥12 weeks
  • Glomerular Filtration Rate (GFR) > 40mL (milliliter)/min; Creatinine ≤ 1.5 x ULN (Upper limit of Normal)
  • Platelets ≥100,000/uL (microliter)
  • Hemoglobin ≥ 9g/dL
  • Absolute Lymphocytes ≥800/uL
  • Absolute neutrophil count/absolute granulocyte count ≥1500/uL
  • Total bilirubin ≤ 2.0 X ULN, or ≤ 3.0 X ULN (for patients with Gilbert's Syndrome)
  • aspartate aminotransferase, alanine aminotransferase ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastasis present)
  • Normal clinical assessment of pulmonary function
  • Negative serum pregnancy test if female and of childbearing potential
  • Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
  • Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Exclusion Criteria:

  • No women who are pregnant or nursing
  • No known hypersensitivity to gemcitabine or nab-paclitaxel
  • No concurrent herbal or unconventional therapy
  • No prior therapy with IL-15 or IL-15 analog
  • No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 or baseline before administration of the study treatment.
  • No positive Hep C serology or active Hep B infection
  • No congestive heart failure < 6 months
  • No unstable angina pectoris < 6 months
  • No myocardial infarction < 6 months
  • No history of ventricular arrhythmias or severe cardiac dysfunction
  • No history of uncontrollable supraventricular arrhythmias
  • No New York Heart Association Class > II congestive heart failure
  • No marked baseline prolongation of QT/QTc interval
  • No known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • No known prior organ allograft or allogeneic transplantation
  • No known HIV-positive or AIDS unless patient is on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 (cluster of differentiation 4) counts >350, with no detectable viral load on quantitative polymerase chain reaction test
  • No untreated central nervous system metastases, or if treated must be neurologically stable for at least 2 weeks prior to enrollment
  • No corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
  • No psychiatric illness/social situation that would limit compliance
  • No other illness that in the opinion of the investigator would exclude the subject from participating in the study
  • No active systemic infection requiring parenteral antibiotic therapy
  • No anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start
  • No disease requiring systemic immunosuppressive therapy
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years after surgical treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559674


Locations
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United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Altor BioScience
Investigators
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Study Chair: Hing C. Wong, Ph.D. Altor BioScience

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Responsible Party: Altor BioScience
ClinicalTrials.gov Identifier: NCT02559674     History of Changes
Other Study ID Numbers: CA-ALT-803-01-15
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Altor BioScience:
Cancer
Advanced Pancreatic Cancer
Interleukin-15
Solid Tumor
Pancreas
Pancreatic
Immunotherapy
Immunotherapeutic
Gemcitabine
Nab-paclitaxel
Metastatic Disease
Combination Immunotherapy

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs