Lung Cancer Clinical Trial on Seneca Valley Virus-001 After

« Go Back to Match Results

Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Complete the Trial Form Below:

Check eligibility to participate in the study

Enter your zip code

We'll show you investigators/research sites in this zip.
We will contact upto 3 sites within 100 Miles

Checking your qualification...

Fetching investigators nearest to you...

Qualification Message

‹

Unfortunately, you did not qualify for this study. See details

You may qualify for a future study, please enter your contact information below to get notified.

Your Name:

Enter your name
Email:

Your email helps investigators to follow up with you.
Phone:

Your phone number helps investigators to follow up with you.
By clicking this button you agree to our privacy and terms of service policies. Your information is kept completely confidential and shared only with the clinical trial personnel.

Send Message to Investigator

‹‹ Go Back

Your Name:

Enter your name
Email:

Your email helps investigators to follow up with you.
Phone:

Your phone number helps investigators to follow up with you.
Preview Your Message

Click to see the preview of your message

Sending...

By clicking this button you agree to our privacy and terms of service policies. Your information is kept completely confidential and shared only with the clinical trial personnel.

Study Description

You may be eligible for this study if you meet the following criteria:

Conditions: Lung Cancer
Age: Between 18 - 100 Years
Gender: Male or Female
+
Inclusion Criteria:

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)

No mixed histology

Presence of ≥ 1 neuroendocrine marker (synaptophysin, NSE, or chromogranin A) in

tumor tissue

Achieved partial response (PR), complete response (CR), or stable disease (SD) within

4 weeks of completing 4-6 courses of platinum-based chemotherapy for extensive-stage

SCLC

Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose

longest diameter can be accurately measured as ≥ 2.0 cm but < 10 cm by chest

x-ray OR as ≥ 1.0 cm but < 10 cm by CT scan, CT component of a PET/CT scan, or

MRI

If CT scan is used, it must be used for both pre- and post-treatment tumor

assessments

Measurable disease is not required for patients with CR

Brain metastases allowed provided they have been stable for ≥ 4 weeks after

completion of prior radiotherapy

PATIENT CHARACTERISTICS:

ECOG performance status 0 or 1

Life expectancy of ≥ 8 weeks

ANC ≥ 1,500/μL

Platelet count ≥ 100,000/μL

Hemoglobin ≥ 9 g/dL

Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal

AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use adequate contraception

Able to comply with study procedures to minimize virus exposure to others

Willing to provide required biologic specimens

Adequate lung function (i.e., not oxygen dependent)

No second primary malignancy within the past 5 years, except for the following:

Carcinoma in situ of the cervix

Non-melanomatous skin cancer

History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if

diagnosed < 5 years prior to study entry)

Stage I breast cancer that was treated ≥ 5 years before study entry

Transitional cell carcinoma of the bladder (in situ)

No active hepatitis B or hepatitis C

No clinically significant infection

No significant traumatic injury within the past 4 weeks

No concurrent uncontrolled illness including, but not limited to, ongoing or active

infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac

arrhythmia, or psychiatric illness/social situation that would limit compliance with

tudy requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Recovered from prior radiotherapy (alopecia allowed)

More than 365 days since prior immunotherapy or biologic therapy

More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to

keletal metastases)

No prior radiotherapy to > 25% of bone marrow

More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy

More than 2 weeks since prior minor surgery*

No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative

erum antibodies

No concurrent combination antiretroviral therapy for HIV-positive patients NOTE:

*Insertion of a vascular access device is not considered major or minor surgery

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)

No mixed histology

Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor

tissue

Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12

weeks of completing 4-6 courses of platinum-based chemotherapy regimen for

extensive-stage SCLC

Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose

longest diameter can be accurately measured as ≥ 2.0 cm but < 10 cm by chest

x-ray OR as ≥ 1.0 cm but < 10 cm by CT scan, CT component of a PET/CT scan, or

MRI

If CT scan is used, it must be used for both pre- and post-treatment tumor

assessments

Measurable disease is not required for patients with CR

Brain metastases allowed provided they have been stable for ≥ 4 weeks after

completion of prior radiotherapy

PATIENT CHARACTERISTICS:

ECOG performance status 0 or 1

Life expectancy of ≥ 8 weeks

ANC ≥ 1,500/μL

Platelet count ≥ 100,000/μL

Hemoglobin ≥ 9 g/dL

Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal

AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use adequate contraception

Able to comply with study procedures to minimize virus exposure to others

Willing to provide required biologic specimens

Willing to return to NCCTG/CTSU enrolling institution for follow-up

Adequate lung function (i.e., not oxygen dependent)

No second primary malignancy within the past 5 years, except for the following:

Carcinoma in situ of the cervix

Non-melanomatous skin cancer

History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if

diagnosed < 5 years prior to study entry)

Stage I breast cancer that was treated ≥ 5 years before study entry

Transitional cell carcinoma of the bladder (in situ)

No active hepatitis B or hepatitis C

No clinically significant infection

No significant traumatic injury within the past 4 weeks

No concurrent uncontrolled illness including, but not limited to, ongoing or active

infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac

arrhythmia, or psychiatric illness/social situation that would limit compliance with

tudy requirements

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

More than 4 weeks since prior radiotherapy, including WBRT, PCI, or Gamma Knife (2

weeks for palliative radiotherapy to skeletal metastases)

Recovered from prior radiotherapy (alopecia allowed)

No prior consolidation radiation therapy to the chest

No prior radiotherapy to > 25% of bone marrow

More than 365 days since prior immunotherapy or biologic therapy

More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy

More than 2 weeks since prior minor surgery*

No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative

erum antibodies

No concurrent combination antiretroviral therapy for HIV-positive patients NOTE:

*Insertion of a vascular access device is not considered major or minor surgery.

Participation Details

RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer. PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.

Additional Information

OBJECTIVES: Primary - To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo. Secondary - To compare the overall survival (OS) of patients treated with NTX-010 vs placebo. - To describe the adverse events profile and safety of NTX-010 in this patient population. - To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population. - To assess the quality of life of this patient population. Exploratory - To determine the relationship between the presence of neutralizing antibodies and PFS. - To assess whether or not a slow viral clearance is associated with better response as determined by PFS. - To determine any potential impact of the presence of one or several neuroendocrine markers in the tumor sample (synaptophysin, chromogranin, or CD56) on PFS and OS. - To determine any potential relationship between presence of cell surface determinants of NTX-010 tropism in the tumor tissue and clinical outcomes such as improved PFS and OS. - To determine any potential relationship between the loss of integrity of IFN signaling in the tumor tissue and clinical outcomes such as improved PFS and OS. - To assess whether or not the presence of circulating tumor cells permissive to NTX-010 is associated with better clinical outcomes as determined by PFS and OS. OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), tumor response to standard chemotherapy (partial response vs stable disease vs complete response), and time between completion of chemotherapy to randomization (1 month vs 2 months vs 3 months). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1. - Arm II: Patients receive a single dose of placebo IV over 1 hour on day 1. In both arms, patients may also undergo prophylactic cranial irradiation (PCI) daily on days 22-35 if they have not previously undergone PCI or whole-brain radiotherapy. Quality of life is assessed at baseline and then periodically during the study. Blood samples are collected periodically for viral clearance and antiviral neutralizing antibody levels, circulating tumor cells, and other biomarker laboratory studies. After completion of study therapy, patients are followed up periodically for up to 5 years.

Source: ClinicalTrials.gov

Clinical Trial Identifier: TX93799

Trial open to limited number of participants

93 users have viewed this page

Need Help?Contact us

Send a Message to TrialX

Your Email:
Your Phone:
Your Message:

Not interested in this trial? Register to get notified for future clinical trials.

As Seen On:

Sites: Cure Talk Cure Byte CELEBS INFO

Sitemaps: Cure Talk Cure Byte Treatment CELEBS INFO

Complete the Trial Form Below:

Check eligibility to participate in the study

Unfortunately, you did not qualify for this study. See details

You may qualify for a future study, please enter your contact information below to get notified.

Your information has been saved successfully. We will notify you incase a matching trial comes up

You might also be interested in other neoplasms pulmonary clinical trials in your area

Study Description

Participation Details

Additional Information

Thank You for contacting TrialX. We've received your message and we'll get back to you in 24hrs.

Send a Message to TrialX

Your message has been sent! Thank you for using the MMRF Patient Navigator Service.

To Email:
Your Email:
Your Name:
Your Message:
	I found a clinical trial, Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer on the Trialx Patient Navigator Website. Please click or copy paste the following link: https://trialx.com/clinicaltrial/93799/lung-cancer-seneca-valley-virus-001-after/