Squamous Cell Carcinoma of the Head and neck (SCCHN)
Non-viral-associated head and neck squamous cell carcinoma (HNSCC) or HPV-associated HNSCC after failure of prior therapy
Squamous cell carcinoma of the head and neck;
Pathologically confirmed head and neck squamous cell carcinoma (HNSCC)
Histologically or cytologically confirmed diagnosis of stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck not suited for local therapy
Has a history of re-irradiation for squamous cell carcinoma of the head & neck (SCCHN) at the projected injection site.
Diagnosis of unknown primary squamous cell carcinoma of the head and neck
Participants must have a pathologic cancer diagnosis:\r\n* COHORT I: Squamous cell carcinoma of the head and neck, nasopharyngeal cancer, or salivary gland cancer\r\n* COHORT II: Solid tumor to the head and neck amenable to palliative treatment, including but not limited to squamous cell carcinoma, adenocarcinoma, sarcoma, melanoma, NK/T lymphoma, poorly differentiated thyroid cancer, and anaplastic thyroid cancer
Squamous head and neck cancer
No previous surgery, radiation therapy or chemotherapy for head and neck squamous cell carcinoma (SCCHN) (other than biopsy or tonsillectomy) is allowed at time of study entry
Histologically-proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy; new primary is allowed if location is in a previously irradiated field; biopsy is recommended for each recurrence but is not mandated per study; this will be at the discretion of the principal investigator
COHORT B, GROUP 4: HEAD AND NECK SQUAMOUS CELL CANCER: Patients with head and neck squamous cell carcinoma must have failed a platinum based chemotherapy regimen that was administered for advanced disease with a palliative intent: patients treated with concurrent platinum agent and radiation as definitive therapy are not eligible unless they subsequently received another line of systemic therapy
Histologically proven recurrent/metastatic squamous cell carcinoma arising from a previous head and neck primary site, and located within the head and neck region, lung or bone, and who are not candidates for curative intent therapy
Patients must have histologically confirmed squamous cell carcinoma of the head and neck (unresectable and not amenable to curative intent therapy)
Histologically proven advanced or metastatic non-small cell lung cancer or squamous cell carcinoma head and neck with tumor at least 1 cm in size
Colorectal cancer/carcinoma (CRC), glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), or squamous non-small cell lung cancer (sqNSCLC)
Histologically documented progressive squamous cell head and neck cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Previously untreated, histologically proven, surgically resectable primary squamous cell carcinoma of the head and neck, stage III or IV (human papilloma virus [HPV] positive or negative non-metastatic disease); SCCHN of unknown primary is excluded; SCCHN of the oral cavity is allowed; unambiguously squamous Epstein-Barr virus (EBV)-negative nasopharynx cancer will not be excluded nor will unambiguously squamous cancers of the skull base that are clearly surgically resectable and clearly squamous; squamous skin cancer occurring in the head/neck region will not be eligible nor will EBV+ nasopharynx cancer\r\n*Note: Induction chemotherapy is not considered standard therapy for SCCHN of the oral cavity and participation on this trial will lead to a delay in time to definitive, potentially curative therapy i.e, surgery
Patients must have either a histologically-confirmed metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck.
Diagnosis of head and neck squamous cell carcinoma that is either biopsy proven or suspected based on history, physical, and or radiographic findings, and who are planned for definitive resection of the tumor without the use of neoadjuvant chemotherapy or radiation therapy at Thomas Jefferson University Hospital (TJUH) are eligible to participate
Received prior cancer therapy for the head and neck squamous cell carcinoma (HNSCC) that is being resected
Histologic diagnosis of cutaneous squamous cell carcinoma of the head and neck that has been resected with no evidence of gross residual disease (margin positivity is acceptable)
Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck (e.g. paranasal cavity) and non-squamous histologies (e.g. nasopharynx or salivary gland)
Patients must have pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving the oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses or unknown primary squamous carcinoma limited to the head and neck region\r\n* Cohort 1: unresectable locally advanced non-nasopharyngeal squamous cell carcinoma of the head and neck (SCCHN) without evidence of distant metastases\r\n* Cohort 2: patients with non-nasopharyngeal SCCHN who have undergone gross total surgical resection within 63 days prior to registration; patients must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension, invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, or the presence of multilevel nodal disease; patients must be without evidence of distant metastases
Limited neck dissections retrieving ? 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck that are positive for squamous cell carcinoma are sufficient for diagnosis pending pathology review at participating institutions.
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck that is metastatic or recurrent and not treatable with curative intent
No previous surgery, radiation therapy or chemotherapy for squamous cell carcinoma of the head and neck (SSCHN) (other than biopsy or tonsillectomy) is allowed at time of study entry
Patients with recurrent/previous treated head and neck squamous cell carcinoma that is deemed surgically resectable by the treating physician but at high risk for recurrence; this group otherwise would be considered for retreatment with radiation and/or chemoradiation
Histologically documented squamous cell head and neck cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Histologically documented diagnosis of squamous cell carcinoma of the head/neck including nasopharyngeal carcinomas (lymphepithelioma histology is ok if criteria 2 is met)\r\n* Patients must have progressed on prior platinum based therapy (or have become intolerant) prior to enrollment on this study
ARM B COHORT 2: Patients must have a histologically confirmed diagnosis of head and neck (squamous cell) carcinoma
For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)
The patient has had prior head and neck squamous cell carcinoma (HNSCC), with the exception of superficial cutaneous basal cell or squamous cell carcinomas
Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) or squamous head and neck cancer (cohort 2) for which there is no curative therapy available.
Malignant solid tumor (e.g. squamous cell carcinoma of the head/neck/cervix) within 2 years if HCT
History of squamous cell carcinoma of the head/neck/cervix within 2 years of HSCT
No previous surgery, radiation therapy or chemotherapy for squamous cell carcinoma of the head and neck (SSCHN) (other than biopsy or tonsillectomy) is allowed at time of study entry
Head and neck cancer - squamous cell
Arm C patients must have loco-regional recurrent head and neck squamous cell carcinoma (HNSCC), excluding endolaryngeal recurrence, meeting the following criteria:
Biopsy-proven, primary or recurrent advanced-stage (III/IV) cutaneous squamous cell carcinoma of the head and neck.
Prior treatment with cabozantinib or pembrolizumab; or any prior immunotherapy for treating squamous cell carcinoma of the head and neck
Recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck
Have histological diagnosis of squamous cell cancer of the head & neck with confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not required
Pathologically confirmed squamous cell carcinoma of the head and neck (SCCHN), not previously treated
Biopsy proven squamous cell carcinoma of the head and neck (SCCHN)
Any head and neck cancer of non-squamous histology
Patients must have histologically-proven recurrent and/or metastatic squamous cell carcinoma of the head and neck that is unresectable; patients in the phase II portion of the trial must have measurable disease
Prior history of head and neck radiation for head and neck squamous cell carcinoma to no more than 72 Gy and most (> 75%) of the recurrent or second primary tumor volume should be in areas previously irradiated to > 45 Gy
Confirmed squamous cell head and neck cancer
Histologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC (squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma.
1a. Head and Neck Stage III/IV squamous cell carcinoma; Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant, primary, recurrent or metastatic setting (or within 9 months if the patient received > 1 platinum-based chemotherapy regimen in the metastatic setting). Active brain metastases or leptomeningeal metastases are excluded; nasopharyngeal cancer, confirmed recurrent or metastatic carcinoma of the nasopharynx and salivary gland or non-squamous histologies are also excluded.
Patients must have histologically or cytologically confirmed head and neck squamous cell cancer (HNSCC) including paranasal sinus cancers but excluding nasopharyngeal carcinomas
Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck
Squamous cell carcinoma of head and neck sites, including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites; patients with a diagnosis of nasopharyngeal carcinoma, or squamous cell carcinoma (SCC) of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites, are eligible
Previous treatment with an EGFR monoclonal antibody (except for past treatment for squamous cell carcinoma of head and neck or metastatic colorectal cancer).
Non-squamous cell carcinomas of the head and neck region i.e. nasopharyngeal carcinoma (World Health Organization [WHO] type II and III) and salivary gland carcinomas
Histologically- or cytologically-confirmed recurrent or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck;
Patients must have histologically confirmed HNSCC, from any primary site; nasopharyngeal carcinoma, World Health Organization [WHO] type I (keratinizing), will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included
Histologically confirmed squamous cell carcinoma of any other primary anatomic location in the head and neck
Patients must have histologically squamous cell carcinoma of the head and neck and be planned for definitive radiation and chemotherapy
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
Histologically/cytologically confirmed diagnosis of squamous cell carcinoma of head and neck origin not amenable to curative intent therapy; both human papillomavirus (HPV)(+) and HPV(-) tumors are eligible; tumors (squamous histology) of unknown primary that are clearly of squamous histology and likely related to the head and neck area are eligible
Patient must have histologically or cytologically confirmed diagnosis of incurable metastatic or recurrent head and neck squamous cell carcinoma
No previous surgery, radiation therapy or chemotherapy for squamous cell carcinoma of the head and neck (SSCHN) (other than biopsy or tonsillectomy) is allowed at time of study entry
Histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma OR histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence); patients may have local stage I or II, or locoregionally advanced HNSCC stage III or IV of the oral cavity, oropharynx, larynx, hypopharynx, or unknown primary, but no metastatic disease; intent to treat with primary radiotherapy +/- chemotherapy
Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.
Metastatic colorectal cancer or head and neck squamous cell carcinoma
Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
Histologically proven squamous cell carcinoma of the head and neck with measurable disease that is either recurrent after attempted cure with surgery and/or radiation therapy or newly diagnosed disease with distant metastases or incurable at diagnosis
No prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or fluorouracil [5-FU]) as part of that regimen
Prior chemotherapy for metastatic squamous cell carcinoma of the head and neck; subjects who have received chemotherapy as part of a multi-modality curative approach for head and neck cancer will be eligible as long as they have not received either docetaxel or capecitabine (or 5-FU) as part of that regimen
Squamous cell carcinoma of the Head and Neck
Patients scheduled for definitive head and neck squamous cell carcinoma (HNSCC) cancer surgical resection less than 9 days from enrollment or greater than five weeks from enrollment
Head and neck squamous cell carcinoma
Subjects with advanced/metastatic Squamous cell carcinoma of the head and neck (SCCHN) who are without options for curative treatment
A minimum of 4 Squamous Cell Carcinomas of the Head and Neck (Sq-HNC)
Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Part B- Diagnosed with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma, uveal melanoma with liver with metastasis, or cholangiocarcinoma
Part C - Diagnosed with head and neck squamous cell carcinoma and have received at least one prior platinum-based systemic therapy
Ability to swallow capsules, with the exception of head and neck squamous cell carcinoma participants who may have study drug crushed and administered through a feeding tube
Histologically documented diagnosis of locally advanced or metastatic squamous cell carcinoma (SCC) of the head and neck no longer amenable to curative surgical resection or radiation therapy
Patients being treated for oropharyngeal cancer with undergoing concurrent chemotherapy and radiation therapy (photons) for a histological diagnosis of squamous cell carcinoma to the head and neck at the University of Pennsylvania
Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region
Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, acininc cell carcinoma, adenocarcinoma, sarcoma)
Patients with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patients
History of prior head and neck squamous cell carcinoma (HNSCC) unless curatively treated for >= 1 year
Participants with premalignant lesions (mild dysplasia, moderate dysplasia, severe dysplasia, or carcinoma in situ) of the head and neck, as confirmed by biopsy within the 4 months prior to study entry or a treated primary T1N0 or T2N0 squamous cell carcinoma will be eligible
Head and neck squamous cell carcinoma:
Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN)
History of malignancy within the last 2 years other than squamous cell carcinoma of the head and neck (SCCHN) and superficial non-melanoma skin cancer; patients with a history of SCCHN must be free of active carcinoma
Patients with biopsy-proven oral squamous cell carcinoma (SCC) who are scheduled to undergo surgery in the Memorial Sloan Kettering (MSK) Head and Neck Service
Group 2 patients:\r\n* Biopsy proven recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)\r\n* Patients planning to undergo investigational therapy
Dosimetry Studies Arm (Completed July 2015): \r\n* Healthy volunteer OR participant with biopsy-proven diagnosis of head and neck squamous cell carcinoma (HNSCC), any histopathologic type of lung cancer, or any other type of cancer that can be treated with platinum-based chemotherapy (which includes but is not limited to ovarian, lung, gastric, hepatic, and pancreatic cancers)
Patients undergoing staging endoscopy for head and neck squamous cell carcinoma (HNSCCa)
Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
Biopsy proven, squamous cell carcinoma of the head and neck
Participant with histologic confirmation of newly diagnosed squamous cell carcinoma (SCC) of the head and neck
Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
Histologically or cytologically confirmed head and neck squamous cell carcinoma.
Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies); any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed
Radiation oncology patients undergoing 6-7 weeks of definitive radiation therapy for stage III-IV head and neck squamous cell carcinoma (HNSCC)