Recurrent Disease Clinical Trial
Official title:
A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
Verified date | September 2019 |
Source | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
Status | Terminated |
Enrollment | 54 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation - Recurrence must be confirmed by anatomopathology (cytology or biopsy) - At least one measurable lesion by MRI or CT-scan - Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen - Patients ineligible for chemotherapy could be included in first line - ECOG performance status 0 -2, in stable medical condition - Patients must be able to swallow tablets - Patients must have an expected survival of at least 3 months - Paraffin-embedded tumor tissue available for immunohistochemistry - Patients must be over 18 years old and must be able to give written informed consent - Women of child-bearing age must have a negative pregnancy test - Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection - Patients must have normal organ function - For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later) - Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis - Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248 - Signed informed consent prior to beginning protocol specific procedure Exclusion Criteria: - Non-squamous head and neck cancer - Nasopharynx cancer - Brain metastases - More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent) - Surgery or irradiation or investigational drugs within 4 weeks before study inclusion - Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …) - Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%) - Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Other concomitant anticancer therapies - Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria. - Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universiatires St LUC UCL | Bruxelles | |
Belgium | clinique Sainte Elisabeth | Namur | |
Belgium | Clinique universiataire de Mont Godinnes UCL | Yvoir | |
France | Centre Jean Perrin | Clermont Ferrand | |
France | Centre G-f Leclerc | DIJON Cedex | |
France | Centre Alexis Vautrin | Nancy | |
France | René Gauducheau | Saint Herblain Cedex | |
France | CHU Bretonneau | Tours cedex 1 | |
France | Institut Gustave Roussy | Villejuif Cedex |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration) | every 6 weeks | ||
Secondary | Determine the safety profile of SU011248 alone in patients with head and neck cancer. | untill disaese progression | ||
Secondary | Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival. | untill disease progression | ||
Secondary | Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses. | at week 6 and at disaese progression after recist response |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02204761 -
Proton Beam Re-Irradiation in Thoracic Cancers
|
N/A | |
Completed |
NCT01445080 -
Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia
|
Phase 1/Phase 2 | |
Terminated |
NCT03525392 -
Study to Evaluate the Safety and Activity (Including Distribution) of 177Lu-3BP-227 in Subjects With Solid Tumours Expressing Neurotensin Receptor Type 1.
|
Phase 1 | |
Completed |
NCT01794845 -
Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
|
Phase 2 | |
Completed |
NCT02210858 -
Tipifarnib in Treating Patients With Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or Undifferentiated Myeloproliferative Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT05432518 -
Pilot Trial for Treatment of Recurrent Glioblastoma
|
Early Phase 1 | |
Completed |
NCT00351975 -
Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases
|
Phase 1 | |
Completed |
NCT03060096 -
Stepped-Care Telehealth for Distress in Cancer Survivors
|
N/A | |
Not yet recruiting |
NCT03591666 -
A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
|
Phase 2 | |
Completed |
NCT00036738 -
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
|
Phase 2 | |
Recruiting |
NCT05260671 -
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN
|
Phase 2 | |
Completed |
NCT01737450 -
Activity and Safety Study of BKM120 in Monotherapy in Patient With Metastatic Head and Neck Cancer Recurrent or Progressive
|
Phase 2 | |
Completed |
NCT03415477 -
Denosumab: A Potential Treatment Option for Aneurysmal Bone Cysts
|
Phase 1/Phase 2 | |
Recruiting |
NCT06088719 -
Safety of Omitting Axillary Surgery in Breast Cancer Patients With Isolated Chest Wall Recurrence
|
||
Terminated |
NCT02488512 -
Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas
|
Phase 2 | |
Recruiting |
NCT02747732 -
Study of Ibrutinib in Combination With Bendamustine and Rituximab for Patients With Relapsed/Refractory Aggressive BCL
|
Phase 2 | |
Completed |
NCT00383474 -
Tipifarnib and Bortezomib in Treating Patients With Acute Leukemia or Chronic Myelogenous Leukemia in Blast Phase
|
Phase 1 | |
Completed |
NCT00003145 -
Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT06014619 -
Complications and Recurrences After Mohs Micrographic Surgery and Slow Mohs
|
||
Active, not recruiting |
NCT03792256 -
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
|
Phase 1 |