Research ProgramsDisease-based ProgramsHead and Neck CancerClinical TrialsClinical Trial InformationThe following clinical trials are available through the Dana-Farber Cancer Institute Center for Head and Neck Oncology. This list only summarizes patient eligibility criteria. For specific eligibility inquiries or other questions, please contact the Clinical Research Coordinator listed at the end of each trial description.
Many of the studies listed below also include a direct link to the National Cancer Institute's PDQ database for more detailed information.
Investigational Curative Therapy04-006 A Randomized Phase III Trial Comparing Sequential Therapy with TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concomitant Boost Radiotherapy (CRT) For Locally Advanced Squamous Cell Cancer of the Head and NeckObjectives:To compare the three-year survival achieved by Docetaxel/Cisplatin/5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN; compare the two-year progression free survival achieved by Docetaxel/Cisplatin/5-fluorouracil (TPF) based sequential therapy with platinum based chemoradiotherapy in patients with locally advanced SCCHN; compare survival at five years, progression-free survival at three and five years and the rate of complete response after all therapy; determine and compare site-specific survival within and between each arm; compare functional organ preservation in each arm, the toxicity of each treatment regimen and quality of life; and establish tissue and germ line correlates of response, local regional control, and distant metastases in each arm.Eligibility:Histologically or cytologcially proven squamous cell carcinoma of the head and neck. Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. At least one uni- or bi-dimensionally measurable lesion. Age ≥18 years. No previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least five years. Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.If you have questions or would like further information about this trial, please contact Britta Andreozzi at (617) 582-8039. 06-128 A Phase I Study of Cetuximab/Docetaxel/Cisplatin/5-Fluorouracil (C-TPF) in Patients with Newly Diagnosed Locally Advanced Squamous Cell Carcinoma of the Head and NeckObjectives:The primary objective for this clinical trial is to determine the maximum tolerated dose of 5-Fluorouracil in Docetaxel/Cisplatin/5-Fluorouracil (TPF) induction chemotherapy when combined with Cetuximab (C) for locally advanced squamous cell cancer of the head and neck (SCCHN). The secondary objectives are to assess the toxicity of the combination and to determine the response rate (Complete Response and Partial Response) of the combined C-TPF in patients with newly diagnosed SCCHN. Eligibility:Histologically or cytologically proven squamous cell carcinoma of the head and neck. Eligible sites: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx or unknown primary site. Stage III or IV disease without evidence of distant metastases. At least one uni- or bi-dimensionally measurable lesion. Age ≥ 18 years. No previous surgery, radiation therapy or chemotherapy for SCCHN (except biopsy or tonsillectomy). No previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. If you have questions or would like further information about this trial, please contact Britta Andreozzi at (617) 582-8039. 05-401 A Phase I Study of Panitumumab plus Chemoradiotherapy and Induction Chemotherapy in Patients with Locally Advanced Squamous Cancer of the Head and NeckPrimary objective:The primary objectives of this study are to identify the maximally tolerated dose (MTD) (or biologically acceptable dose, in the absence of MTD-defining DLT) of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy (Pan-CRT) and to identify the MTD or biologically acceptable dose of TPF, varying the 5-FU dose, given with a fixed dose of panitumumab, prior to concurrent carboplatin, paclitaxel, panitumumab chemoradiotherapy. Secondary objectives include:
Eligibility:To be eligible for the study, patients must fulfill all of the following criteria:
If you have questions or would like further information about this trial, please contact Rafia Khan at (617) 582-8013. 06-283 Randomized Phase II Study Of Docetaxel In Combination With ZACTIMA (ZD6474) In Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)Primary Objectives:
Eligibility:Patients must have:
Patients must not have had:
If you have questions or would like further information about this trial, please contact Jayme Flynn at (617) 632-5260. 07-041 A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Over-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm Objectives: The purpose of this study is to estimate the effect of panitumumab on progression free survival when added to combination chemotherapy in treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN). The study will also examine response to treatment, and overall survival and safety of the treatment. Eligibility:
If you have questions or would like further information about this trial, please contact Rafia Khan at (617) 582-8013. Chemoprevention05-361 Bowman Birk Inhibitor Concentrate and Oral Leukoplakia: a Randomized Phase IIb TrialObjective:The purpose of this study is to conduct a placebo-controlled, double-blind and randomized 6 month phase IIb cancer control chemoprevention trial of the Bowman-Birk Inhibitor Concentrate (BBIC) in patients with Oral Leukoplakia (OL). This study is being performed to determine whether a product made from soybeans named Bowman-Birk Inhibitor Concentrate (BBIC) affects oral precancerous lesions known as oral leukoplakia (white patch) or erythroplakia (red patch). These types of lesions sometimes, but not always, develop into oral cancer. One of the purposes of this research is to compare the effectiveness of BBIC to an inactive material (called a "placebo") to see if BBIC has any effect on these patches. Another purpose of the study is to see if there are any side effects when taking this medication.Eligibility:Patients must have clinically and histologically proven oral leukoplakia and/or erythroplakia and be ≥18 years of age. Women of childbearing potential must not be pregnant and must be willing to use adequate birth control methods. Patients will not be eligible if there has been the use of systemic steroids, or topical oral steroid preparations within three months of the study.If you have questions or would like further information about this trial, please contact Jayme Flynn at (617) 632-5260. Trials for patients with recurrent disease05-379 A Phase II, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinum® in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Received At Least One Prior Anti-cancer Treatment Regimen for Recurrent DiseasePrimary objective:To determine the safety, tolerability, and recommended dose (RD) of intratumorally injected Proxinium® in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) who have received at least one prior anti-cancer treatment regimen for recurrent disease. Secondary objectives:
Eligibility:
If you have questions or would like further information about this trial, please contact Sonia Kim at (617) 632-5587. Primary objective:
The primary objective of this study is to evaluate the rate of disease control (i.e., achievement of complete response, partial response, or stable disease) of the single agent depsipeptide in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck. Secondary objective:
The secondary objective of this study is to evaluate the duration of response, time to progression, and overall survival for patients with incurable head and neck cancer treated with depsipeptide. Eligibility:To be eligible for the study, patients must fulfill all of the following criteria:
If you have questions or would like further information about this trial, please contact Jayme Flynn at (617) 632-5260. 06-111 Randomized Phase II Study of Bevacizumab/Tarceva® and Tarceva®/Sulindac in Squamous Cell Carcinoma of the Head and NeckPrimary Objective:The primary objective of this randomized Phase II study is to evaluate the efficacy of erlotinib (also called Tarceva®) plus bevacizumab (also called Avastin®) (Arm A) or erlotinib (Tarceva®) plus sulindac (Arm B) in subjects with incurable recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), as measured by progression-free survival (PFS). Secondary Objective:Secondary objectives include: evaluation of the overall response rate (ORR) of erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in subjects with incurable SCCHN; evaluation of the duration of overall survival and objective response with erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in this patient population (rates of PFS at 4 months and 1 year will also be determined); evaluation of the safety and side effects of erlotinib (Tarceva®) plus bevacizumab (Avastin®) or sulindac in subjects with incurable SCCHN; and to bank pre- and post-treatment tissue specimens in a subset of subjects for exploration molecular markers associated with response. Eligibility:Subjects must be 18 years of age or older with histologically/ cytologically documented squamous cell carcinoma of the head and neck. Subjects must have evaluable locoregional and/or metastatic disease that is not appropriate for treatment by primary surgical resection or radiotherapy. Subjects must have failed to respond to or relapsed from at least once prior chemotherapy or chemoradiotherapy. Subjects will be excluded from this study if they have had: more than one prior systemic therapy for recurrent and/or metastatic disease, any other malignancy within 5 years (except non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder or head and neck), concurrent anticancer therapy (other than that of this study), treatment with any anticancer drug within 28 days of beginning this study, radiotherapy within 28 days of beginning this study, any prior therapy which targets the ErbB and/or VEGF pathways (including oral kinase inhibitors and antibody therapy), concurrent therapy with any NSAID (except aspirin at a dose of no more than 81 mg per day), known hypersensitivity characterized by acute bronchospasm, urticaria and/or rhinitis to NSAIDs (including aspirin). Subjects will also be excluded form this study if they have other serious illnesses or medical conditions, a tumor that encases the carotid artery (or other major vessel that in the opinion of investigators is at risk for tumor-related hemorrhage), or have the presence of central nervous system or brain metastases. If you have questions or would like further information about this trial, please contact Rafia Khan at (617)582-8013. 06-179 A Pilot Feasibility Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma Objectives: The primary objective for this Pilot study is to determine the feasibility and safety of generating and administering at least 2 infusions of Epstein-Barr Virus (EBV)-specific adoptive T cells in subjects with incurable locoregional relapsed and/or distant metastatic EBV-associated nasopharyngeal carcinoma (NPC). The data collected from this Pilot study will provide the basis for a Phase II study to establish the clinical efficacy of EBV-specific adoptive immunotherapy for the treatment of NPC. Basic science studies aimed at understanding the mechanisms underlying effective EBV-specific immunotherapy will also be initiated in this Pilot study and should allow more advanced studies of specific EBV-associated immune factors in a future Phase II clinical trial. Eligibility: Histologically or cytologically proven NPC of any WHO grade associated with EBV as documented by the presence of EBER by immunohistochemistry in the tumor. Incurable NPC as defined by relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment with no potential curative option OR NPC with distant metastasis. Age > 18 years and ECOG Performance Status ≤ 1. No prior radiotherapy for primary NPC within 8 weeks of enrollment or chemotherapy for NPC within 2 weeks of enrollment. No other cancer within 5 years, with the exception of carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer. No uncontrolled central nervous system metastases. Certain significant medical conditions may be exclusionary. If you have questions or would like further information about this trial, please contact Jayme Flynn at (617) 632-5260. Thyroid Cancer06-188 A Phase II, Open-Label Study to Assess the Efficacy and Tolerability of ZD6474 (ZACTIMA) 100 mg Monotherapy In Subjects with Locally Advanced or Metastatic Hereditary Medullary Thyroid Cancer.Objective:The primary objective of this study is to determine the objective response rate in subjects treated with ZD6474 monotherapy. Secondary objectives are to determine the safety and tolerability of ZD6474 treatment in this patient population, to determine the progression free survival of hereditary MTC in subjects following ZD6474 100 mg therapy, as well as the disease control rate, duration of objective response, and duration of disease control with ZD6474. Secondary objectives also include assessment of performance status as well as bowel frequency changes during therapy, in addition to an assessment of the effect of ZD6474 on calcitonin and CEA levels, and to characterize the population pharmacokinetic of ZD6474 in subjects with hereditary MTC. Eligibility:Potiential subjects must be over 18 years of age, WHO Performance status of 0-2, at least one measureable lesion greater than 1 cm on spiral CT, and women of childbearing potential must have a negative pregnancy test. Only subjects with the hereditary form of medullary thyroid cancer will be eligible for entry into this trial. Subjects must not have brain metastases or spinal cord compression, unless irradiated at least four weeks before the first dose and stable without steroid treatment for greater than one week. Subjects must have had their last surgical procedure, dose of chemotherapy or radiation, at least four weeks before starting study. Subjects must not have significant cardiac issues that put them at risk of ventricular arrhythmia, or asymptomatic sustained ventricular tachycradia, or congenital long QT syndrome, or first degree relative with unexplained death under 40 years of age. Subjects cannot have a left bundle branch block, uncontrolled hypertension, previous malignancies at other sites within five years of study start, with the exception of in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin. Compensation:There may be funds available to aid any patient who wishes to participate, but will require a large travel expenditure. Details regarding travel reimbursement may be discussed further with the study staff. If you have questions or would like further information about this trial, please contact Jeff Miller at (617) 632-2503. 06-252 A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMA) versus Placebo in Subjects with Unresectable Locally Advanced or Metastatic Medullary Thyroid CancerObjective:This will be a Phase II, randomized study to establish the effect of once-daily oral doses of ZD6474 300mg vs placebo in subjects with locally advanced or metastatic hereditary or sporadic medullary thyroid cancer in whom no standard therapeutic option is available. It will be conducted in a minimum of 232 subjects in approximately 58 countries. The subjects may continue with ZD6474 as long as they are receiving clinical benefit or until they are given another anti-cancer therapy. Eligibility:To participate in study you must: Be 18 years or older ; Have confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC ; Have a measurable tumor; Be able to swallow medication You are not able to participate if you have: Had major surgery within 4 weeks before randomization; Received the last dose of prior chemotherapy less than 4 weeks prior to randomization; Had radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy); Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days; Significant cardiac events; Had previous ZD6474 treatment If you have questions or would like further information about this trial, please contact Jeff Miller at (617) 632-2503. 06-321 A Pivotal Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 in Patients with 131I-refractory metastatic or Unresectable locally-advanced papillary, follicular, or Hurthle-cell thyroid cancer who are also refractory to, or intolerant of, or have clinical contraindication to, doxorubicin treatmentPrimary Objective:The primary objective of this study is to determine the objective response rate (ORR) of patients with 131I-refractory metastatic or unresectable locally-advanced papillary, follicular, or Hurthle-cell thyroid cancer who are also refractory to, or intolerant of, or have clinical contraindication to, doxorubicin treatment. Inclusion Criteria:
Exclusion Criteria:
If you have questions or would like further information about this trial, please contact Rafia Khan at (617) 582-8013. PhaseonePhase I Trials06-416 An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects with Advanced Solid TumorsPrimary Objective:The primary objective of this study is to evaluate the effect of AMG 706 monotherapy administered according to three different dosing schemes on the change in size (volume) and function (eject fraction) of the gallbladder.Secondary Objective(s):
Eligibility:Key Inclusion Criteria:
Key Exclusion Criteria:
For further information on this study, please contact the research coordinator for this trial, Jayme Flynn at (617) 632-5260. Phase I/II Trial of Abraxane in Combination with Carboplatin, Erbitux and Intensity Modulated Radiation Therapy (IMRT) for Treatment of Locally Advanced Squamous Cancer of the Head and Neck Objectives: The primary objective for the phase I portion of this clinical trial is to identify the maximally tolerated dose of Abraxane given with carboplatin and Erbitux plus concurrent IMRT (ACE-RT) for locally advanced SCCHN. I In the phase II portion of the study, the objective is evaluate the efficacy of this regimen by evaluating 2-year disease-free survival. The secondary objectives are to evaluate the safety and tolerability of the combination of Abraxane, carboplatin and Erbitux, to estimate the overall response rate to ACE-RT, to estimate 2-year overall survival, and to evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life . Eligibility: Histologically or cytologically proven squamous cell carcinoma of the head and neck. Eligible sites: oral cavity, oropharynx, nasopharynx, hypopharynx, larynx or unknown primary site. Stage III or IV disease without evidence of distant metastases. At least one uni- or bi-dimensionally measurable lesion. Age > 18 years. No previous surgery, radiation therapy or chemotherapy for SCCHN (except biopsy or tonsillectomy). No previous or current malignancies at other sites, with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, bladder or head and neck. No prior therapeutic radiation to the head and neck. No prior therapy which targets the EGFR pathway. If you have questions or would like further information about this trial, please contact Jeff Miller at (617) 632-2503 Non-protocolNon-protocol treatmentsSalivary gland cancer/adenoid cystic carcinoma:Second line chemotherapy with Cytoxan, Adriamycin and Oxaliplatin for patients who have not had prior exposure to these three drugs and who have progressed on other chemotherapy for metastatic or recurrent disease. Cycles are every 3-4 weeks. Recurrent or metastatic nasopharynx cancer:First line salvage for possible cure. ABIM (Adriamycin, Bleomycin, Ifosfamide and Mesna). Patients with metastatic disease, or locally recurrent disease for which further radiation is not recommended, no prior systemic chemotherapy for recurrence, no radiation to sites outside the head and neck. This therapy requires hospitalization for 4 days, a venous access device and careful monitoring. Cycles are every three to four weeks. Radiotherapy is planned for limited stage recurrences. |
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