Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
Tissue acquisition: patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies
Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies
Patients must be offered the opportunity to participate in specimen banking for future studies, to include translational medicine studies
Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies
Patient must be willing to have tissue specimens submitted for translational medicine studies
Patient must be offered the opportunity to participate in tissue and blood banking for future studies
Participants must have accessible tumors and consent to repeated biopsy for performance of correlative tissue studies
Availability of diagnostic tumor tissue specimens for correlative studies
Willing to provide archived tissue for correlative studies. If no archived sample is available the patient will still be eligible
A pretreatment research core biopsy of the primary tumor must be performed with submission of 2 cores for required correlative studies. These specimens will NOT be returned to the site.
Able and willing to undergo the required bone marrow biopsies; correlative studies are strongly encouraged
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted.
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the NCI, POB screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
Subjects must consent to provide archival tumor tissue (initial and subsequent tumor biopsy samples, if possible) for correlative biomarker studies
Patients must be willing to have archived tumor specimens utilized for correlative studies if available
INTRATUMORAL STUDIES PATIENTS:
Subject may also provide consent/assent for future correlative research; subjects may participate in the main trial without participating in future correlative research
Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
Subject may also provide consent/assent for future correlative research; subjects may participate in the main trial without participating in future correlative research
Be willing to participate in the collection of blood and tissue for banking and future correlative studies.
Patients must agree to tissue collection for correlative studies at the specified timepoints.
Available archived tissue biopsies will be provided for correlative studies
Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients, which can be accomplished using the study specific informed consent or another consent, such as the National Cancer Institute (NCI), Pediatric Oncology Branch (POB) screening protocol; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for screening or baseline values even if the studies were done before informed consent was obtained, if the patient agrees
Subjects must provide archived tumor specimens for correlative biomarker studies if sufficient tissue is available; a fresh biopsy is not required
All patients must have provided informed consent for correlative studies
Consents to whole blood collection prior to initiating therapy, on cycle 2 day 1, and at cystectomy for support of correlative research studies
Either enrolled in Human Research Protection Office (HRPO)# 201107221 (“Tissue and blood acquisition for genomic analysis and collection of health information for patients with gastrointestinal cancers”), which facilitates the collection of specimens for correlative studies, or consenting to collection of blood and tissue as part of this protocol for research testing
Fresh or archived tumor specimen should be available for correlative studies as required
Currently receiving or scheduled to receive any other therapies intended to treat the newly diagnosed glioma prior to the MLA and the first post-MLA blood collection for correlative studies
Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated
Consent to baseline metastatic and progressive disease biopsy (of metastatic/progressing lesion) for enabling biomarker assessment and treatment assignment (at each time point – baseline, PD1, PD2, PD3) as well as for correlative studies\r\n* Consent to baseline and serial blood draws for plasma/serum/whole blood banking for correlative studies
Patients must consent to participate in the correlative studies and should have available tumor tissue for tumor biopsies
Able to comply with the protocol, including tissue sampling, imaging studies and surgical intervention
No focal wall motion abnormalities as determined by either of the above studies
Patient must consent to mandatory correlative sample collection
Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided)
Signed informed consent prior to initiation of any study?specific procedure or treatment, including consent to provide blood samples for correlative studies and to obtain a tumor biopsy during the study
Willing to undergo a baseline tumor core needle biopsy for correlative science studies; this study does not restrict eligibility based on PD-L1 expression
Patients must be willing to undergo extra blood sampling for correlative studies
Note: optional tumor biopsies (punch, fine needle aspiration [FNA], core or excisional) at pre-treatment, week 1, and at progression will be presented to subjects considering this study; we anticipate approximately 1-3 patients per cohort to have tumors biopsied for correlative studies; the additional subjects at the recommended phase II dose (RP2D) (expansion cohort) are required to have correlative studies (blood collection and tumor biopsies at the defined time points)
Willingness to provide mandatory blood samples for pazopanib drug level assessments required for dosage adjustments, as well as for required pharmacogenomic studies
Patient has diagnostic tissue available for correlative studies
Patients must be offered the opportunity to participate in specimen banking for future use to include translational medicine studies
Patients must agree to participate in the translational medicine studies
Tumour tissue for central pathology review and correlative studies must be provided.
Tumor tissue for correlative studies is mandatory
Subjects must consent to bank whole blood, serum, plasma for future unspecified studies.
Willingness to provide the biologic specimens and participate in imaging studies as required by the protocol
Tissue acquisition: subject must agree to provide the required research biopsies at baseline, at day 14 (+7 days [d]) and at surgery for biomarker and correlative studies
Institutions must offer patients the opportunity to submit tissue for future correlative studies
Availability of tissue if applicable (from the primary tumor or metastases) for correlative studies.
Archived or fresh tumor sample available; willingness to donate blood and tissue for mandatory correlative research studies
Patients must consent to a research biopsy of tumor tissue at baseline, for conduct of correlative studies; archived biopsy material may not be substituted
Subjects must consent to provide archived tumor specimens and / or tumor biopsy for correlative biomarker studies.
No available tumor material for correlative studies
Patient is willing to have two biopsies while on treatment for correlative studies
Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off study
Unwilling to provide consent for genetic studies of tumor, whole blood, or plasma specimens
All necessary baseline studies for determining eligibility must be obtained within 42 days of registration unless otherwise stated
Patients are offered registration to the correlative study CALGB-151105
Patients must be offered the opportunity to participate in specimen banking for future use to include the translational medicine studies
Tumor tissue from surgery or biopsy must be available to determine MAGE-A3 expression for correlative studies.
Eligible patients will have biopsy (histology or cytology) proven non-squamous, NSCLC with stage IIIA or dry IIIB disease; patients with previously surgically resected NSCLC who have a locoregional recurrence that is clinically amenable to definitive treatment with chemoradiation are also eligible; previous diagnostic tissue may be accepted to confirm diagnosis and perform correlative studies; patients are still eligible if there is insufficient tissue for correlative studies; evidence of mediastinal nodal disease will be documented pathologically by pretreatment mediastinoscopy or EBUS/EUS, only if clinically indicated (i.e. if the staging computed tomography [CT] Scans and positron emission tomography [PET] Scans are equivocal)
All patients or their legal guardians (if the patients is < 18 years old) must sign an institutional review board (IRB) approved document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility); when appropriate, pediatric patients will be included in all discussion in order to obtain verbal assent
Women with and without prior therapy are also eligible; priority will be given to those who consent to participating in the pharmacokinetic studies
Willingness to consent to the use of baseline diagnostic tumor specimen for correlative studies (any diagnostic material will be acceptable- paraffin block, cell block, fine needle aspirate etc.)
All studies required for evaluation will be performed within 8 weeks of Photofrin administration
Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2).
Willingness to provide biologic samples for PIK3CA sequencing and correlative studies
Subjects must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies.
Patient must consent to provision of a sample of blood in order that the specific correlative marker assays may be conducted.
Patients must be offered participation in the translational medicine studies; additionally if patient has biopsy accessible disease they must be offered participation in the translational medicine studies
Diagnostic or laboratory studies performed exclusively to determine eligibility for this trial must only be done after obtaining written informed consent from all patients or their legal guardians (if the patient is < 18 years old); when appropriate, pediatric patients will be included in all discussions; this can be accomplished through one of the following mechanisms: a) the NCI, POB screening protocol, b) an Institutional Review Board (IRB)-approved institutional screening protocol or c) the study-specific protocol; documentation of the informed consent for screening will be maintained in the patient’s research chart; studies or procedures that were performed for clinical indications (not exclusively to determine eligibility) may be used for baseline values even if the studies were done before informed consent was obtained
Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted
Ability to understand and the willingness to sign a written informed consent document; as the correlative studies are critical to the clinical and scientific value of the trial, CD4 count/HIV viral load determinations will be required, and participation in the tumor-based correlative studies will be strongly recommended; additionally, investigators MUST request sample donation to the AIDS Cancer Specimen Resource (ACSR); however, the patient may refuse sample donation; patients accrued to the expansion phase of the study will be required to undergo pharmacokinetic sampling
All patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility) (Cohort 1)
Because significant time will have elapsed between apheresis/tumor biopsy and the initiation of immunotherapy, all patients or their legal guardians (if the patient is < 18 years old) must sign a second informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
All patients or their legal guardians (if the patient is < 18 years old) must sign a document of informed consent (screening protocol) prior to performing studies to determine patient eligibility; after confirmation of patient eligibility all patients or their legal guardians must sign the protocol specific informed consent to document their understanding of the investigational nature and the risks of this study before any protocol related studies are performed (other than the studies which were performed to determine patient eligibility)
Willing to provide mandatory blood and urine specimens for correlative research; NOTE: can be waived with permission of study chair (documentation such as an email must be provided)
Patient with Rheumatoid Arthritis and other inflammatory diseases that would impact the correlative studies
Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment
Obtains a score of > 6 on the shortened Center for Epidemiologic Studies - Depression (CES-D)
Subjects may co-enroll on other investigational studies except for investigational studies whose primary aim is the prevention of GVHD
Tumor imaging studies including
Patients may enroll simultaneously on this study and other studies, including but not limited to NSABP B52
Consent to be contacted for future studies
Both Studies:
Consent to be contacted for future studies
MRI has been performed in Step 1, and additional imaging studies and biopsies performed if indicated
Patients who will have surgical resections must consent to the use of post-surgery tumor samples for correlative molecular studies
Baseline creatinine (necessary for imaging studies)
Willing to undergo two mandatory core biopsies after diagnosis to obtain tissue for correlative studies; the third biopsy time point is optional
Bone marrow and/or peripheral blood specimens will be submitted for correlative studies; patients who have a dry tap will still be eligible