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NCT00753415 · REGISTRY CONDITION SEARCH

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2015-03-17

This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-Limiting Toxicity (DLT)

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outcome · POSTED

Number of Participants With Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria Part A * Participant has one of the selected solid tumors with no distant metastases, and is more than 8 weeks from completion of definitive therapy with intention to cure. Selected Solid Tumors: Stage I to III non-small cell lung carcinoma (NSCLC); Stage III breast cancer; Stage IIB or III melanoma; Stage II or III upper gastrointestinal tract carcinoma (e.g., esophagus, stomach, gallbladder, pancreas); Stage III colon carcinoma; Stage II, III, or IV (M0 only) renal cell carcinoma; Stage II, III, or IV (M0 only) bladder carcinoma; clinically-localized prostate carcinoma * Participant has adequate organ function. * Female participant of childbearing potential has a negative serum pregnancy test within 3 days of study enrollment. Exclusion Criteria Part A * Participant has known hypersensitivity to any component of study vaccine. * Participant has a history of clinically significant cardiac conditions, including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or New York Heart Association (NYHA) Class III or IV congestive heart failure. Participant must have no clinically significant electrocardiogram (ECG) abnormalities and not have a pacemaker or cardioverter/defibrillator implanted. * Participant has undergone splenectomy or has any history of autoimmune disorder. * Participant has received immunosuppressive treatment within 1 month prior to enrollment. * Participant has known acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections. * Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of study entry. * Participant is pregnant or breastfeeding, or expecting to conceive at any time during the study or within 1 year after receiving the last vaccination. * Participant is known to be Human Immunodeficiency Virus (HIV)-seropositive. * Participant has known history of Hepatitis B or C or active Hepatitis A. * Participant has been vaccinated for any disease or for prophylaxis within 1 month prior to the first vaccination. * The participant has been diagnosed with Systemic Lupus Erythematosus (SLE) Inclusion Criteria Part B * Participant must have completed their respective vaccination Treatment Group regimen for Part A of this study. * Participant must have completed a ≥12 week safety observation period prior to receiving their first V934-EP boost. Exclusion Criteria Part B * Participant has new or metastatic tumor lesions since enrollment in Part A. * Participant has developed any significant cardiac conditions since enrollment in Part A including cardiac arrhythmias which have not been controlled within the last 3 months, unstable angina, myocardial infarction (within the last 3 months), or NYHA Class III or IV congestive heart failure. * Participant has undergone a splenectomy, or has developed any autoimmune disorders, since enrollment in Part A. * Participant has received immunosuppressive treatment within 1 month prior to enrollment in Part B * Participant has developed any acquired, inherited, or idiopathic thrombocytopenia, platelet dysfunction or coagulopathy that would contraindicate IM injections * Participant has an acute infection requiring intravenous antibiotic, antiviral or antifungal agents within 2 weeks of entry to Part B.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Two intramuscular (IM) injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    intervention Names
    1. Biological: V935
    label
    Part A: V935 LD
    type
    EXPERIMENTAL
  2. description
    Three electroporation (EP) injections of V934 (LD) , 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (LD) will be administered, 1 given every other week over a 3-week period.
    intervention Names
    1. Biological: V935
    2. Biological: V934-EP
    label
    Part A: V934 LD(3)+V935 LD
    type
    EXPERIMENTAL
  3. description
    Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
    intervention Names
    1. Biological: V935
    label
    Part A: V935 HD
    type
    EXPERIMENTAL
  4. description
    Three EP injections of V934 (HD), 1 given every other week over a 5-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.
    intervention Names
    1. Biological: V935
    2. Biological: V934-EP
    label
    Part A: V934 HD(3)+V935 HD
    type
    EXPERIMENTAL
  5. description
    Five EP injections of V934 (HD), 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) will be administered, 1 given every other week over a 3-week period.
    intervention Names
    1. Biological: V935
    2. Biological: V934-EP
    label
    Part A: V934 HD(5)+V935 HD
    type
    EXPERIMENTAL
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    intervention Names
    1. Biological: V934-EP
    label
    Part B: V935 LD/V934 Booster
    type
    EXPERIMENTAL
  7. description
    Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
    intervention Names
    1. Biological: V934-EP
    label
    Part B: V934 LD(3)+V935 LD/V934 Booster
    type
    EXPERIMENTAL
  8. description
    Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
    intervention Names
    1. Biological: V934-EP
    label
    Part B: V935 HD/V934 Booster
    type
    EXPERIMENTAL
  9. description
    Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
    intervention Names
    1. Biological: V934-EP
    label
    Part B: V934 HD(3)+V935 HD/V934 Booster
    type
    EXPERIMENTAL
  10. description
    Participants who complete Part A can enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster will be administered, 1 given every 2 weeks.
    intervention Names
    1. Biological: V934-EP
    label
    Part B: V934 HD(5)+V935 HD/V934 Booster
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A: V934 HD(3)+V935 HD
    2. Part A: V934 HD(5)+V935 HD
    3. Part A: V934 LD(3)+V935 LD
    4. Part A: V935 HD
    5. Part A: V935 LD
    description
    A 0.5 mL vaccine administered IM every 2 weeks as either a LD (1 x 10\^9 vector genomes/mL) or a HD (1 x 10\^11 vector genomes/mL).
    name
    V935
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Part A: V934 HD(3)+V935 HD
    2. Part A: V934 HD(5)+V935 HD
    3. Part A: V934 LD(3)+V935 LD
    4. Part B: V934 HD(3)+V935 HD/V934 Booster
    5. Part B: V934 HD(5)+V935 HD/V934 Booster
    6. Part B: V934 LD(3)+V935 LD/V934 Booster
    7. Part B: V935 HD/V934 Booster
    8. Part B: V935 LD/V934 Booster
    description
    A 0.5 mL vaccine administered by EP as either a LD (0.5 mg plasmid/mL) or a HD (5.0 mg plasmid/mL).
    name
    V934-EP
    type
    BIOLOGICAL
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
37
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    DLT was defined as a vaccine- or EP-related adverse event (AE) including the following: Hematological (Grade 3 neutropenia with fever, Grade 4 neutropenia ≥5 days, Grade 4 thrombocytopenia) or non-hematological AE, Grade 3, 4 or 5 with the exception of Grade 3 nausea, vomiting, diarrhea or serum glutamic oxaloacetic transaminase (SGOT) elevation, alopecia, Grade 3/4 creatinine phosphokinase (CPK) elevation or inadequately treated hypersensitivity. Any Grade 3/4 related AE that failed to return to ≤Grade 1 or baseline within 14 days was also considered a DLT.
    measure
    Number of Participants With Dose-Limiting Toxicity (DLT)
    time Frame
    Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
  2. description
    This analysis includes the number of participants with AEs and serious AEs (SAEs) during the Treatment Period plus the Acute Follow-up (FU) Period (up to 30 days following last vaccination). An AE was defined as any unfavorable or unintended change in the structure, function or chemistry of the body temporally associated with the use of the product, whether or not considered related to the product, including any worsening of a preexisting condition which was temporally associated with the product. An SAE was defined as an AE resulting in death, was life-threatening, resulted in or prolonged hospitalization, was a congenital anomaly, a cancer, an overdose or other important medical event.
    measure
    Number of Participants With Adverse Events (AEs)
    time Frame
    Day 1 up to 30 days following the last vaccination (up to 77 weeks); Treatment Period + Acute Follow-up (FU) Period
secondary Outcomes
  1. description
    An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
    measure
    Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
    time Frame
    From pre-vaccination to Week 69
Full study description
brief Summary
This is a two-part study to test the safety, tolerability, and immune response for V934/V935 vaccine using a new prime-boost regimen in participants with selected solid tumors.
detailed Description
Two vaccines will be administered: V934-electroporation (EP) either low dose (LD) or high dose (HD), and V935 either LD or HD. In Part A, participants will be assigned to V935 vaccine alone or in combination with V934-EP. Part B will be an optional part of the study, offering V934-EP vaccine booster to participants who were enrolled in Part A.
Source references
references
  1. citation
    Aurisicchio L, Fridman A, Mauro D, Sheloditna R, Chiappori A, Bagchi A, Ciliberto G. Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study. J Transl Med. 2020 Jan 30;18(1):39. doi: 10.1186/s12967-020-02228-9.
    pmid
    32000810
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
      ds-small-intestine-cancer
      source file
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    Preserved source evidence · Not medical advice