Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Xeloda

External Beam Radiotherapy

Zvi Bernstein, MD

Kuten Abraham, Prof.

Hypothesis: Radiosensitization using Xeloda should improve the rate of complete pain relief.

Primary Objective:

* To determine the frequency of pain relief for the proposed regimen.

Secondary Objective(s):

* To determine the duration of pain relief and narcotic relief for the proposed regimen.
* To determine the frequency of narcotic relief for the proposed regimen.
* To determine the toxicity of concurrent UFT and radiotherapy in patients with bone metastases.

Concurrent Xeloda and Radiotherapy for Bone Metastases

Rambam Health Care Campus

Head and Neck Neoplasms

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Celecoxib

Cyclooxygenase 2 Inhibitors

Tubulin Modulators

Antimitotic Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

400mg bid starting 1 week before radiotherapy and taken through radiotherapy.

celecoxib

IV, AUC 2.0, weekly for weeks 1 through 7

IV 30 mg/m2, weekly for weeks 1 through 7

70.2Gy, at 1.8Gy qd, Monday through Friday

Radiation Therapy

Sharon Spencer, M.D.

This is a single-institution, open-label, non-randomized phase IB/II trial of celecoxib administered concurrently with carboplatin, paclitaxel, and radiation therapy in patients with locally advanced or recurrent squamous cell carcinoma of the head and neck.

Treatment for this protocol consists of radiotherapy, 70.2Gy, at 1.8Gy qd, Monday through Friday.Celecoxib 400mg bid is taken during radiotherapy, starting 1 week before radiotherapy. Carboplatin IV, AUC 2.0, weekly for weeks 1 through 7,Paclitaxel 45 mg/m2, weekly for weeks 1 through 7, and Celecoxib 400mg bid, continuing after therapy for two years or until disease progression.

Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer

Radiosensitization With a COX-2 Inhibitor (Celecoxib), With Chemoradiation for Cancer of the Head and Neck

Particpants experiencing Acute Toxicities \> Grade 3

Evaluate the response to concurrent celecoxib, carboplatin, paclitaxel, and radiotherapy in the treatment of locally advanced SSC of the head and neck. Response is determined by local control only, local and distant metastasis, distant metastasis only, second primary, and surgical salvage.

Bristol-Myers Squibb

Pharmacia

University of Alabama at Birmingham

Professor - Radiation Oncology

Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Sharon Spencer Professor of Radiation Oncology

Hematologic

Dermatitis

Mucositis/Dysphagia

Participants that experienced Grade 3 or higher toxicity factors.

Acute Toxicity

Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck.

Local Control Only

Local Control and Distant Metastasis

Distant Metastatsis Only

Secondary Primary - Site Unknown

Surgical Salvage

Recurrence

Response as Evaluated by Recurrence of Diseases

Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.

Overall Study

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Micronutrients

Anti-Infective Agents

Topotecan

Iodine

Cadexomer iodine

3-Iodobenzylguanidine

Topoisomerase I Inhibitors

Radiopharmaceuticals

iodine I 131 metaiodobenzylguanidine

topotecan hydrochloride

chemotherapy

peripheral blood stem cell transplantation

radioisotope therapy

radionuclide imaging

radiosensitization

total-body irradiation

Mark N. Gaze, MD

RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG), releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Topotecan may also make tumor cells more sensitive to iodine I 131 MIBG. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by iodine I 131 MIBG and topotecan. This may allow more iodine I 131 MIBG and topotecan to be given so that more tumor cells are killed.

PURPOSE: This phase II trial is studying how well giving high-dose iodine I 131 MIBG together with topotecan and peripheral stem cell transplant works in treating young patients with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma.

OBJECTIVES:

* Determine response (partial and complete response at metastatic sites) in children with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma treated with high-dose iodine I 131 metaiodobenzylguanidine, topotecan hydrochloride, and peripheral blood stem cell transplantation.
* Determine the proportion of patients who, as a result of this treatment, are able to progress to potentially curative surgery and further systemic treatment.
* Correlate tumor dosimetry (to determine whether the tumor absorbed the radiation dose) with response in patients treated with this regimen.
* Determine the time to tumor progression.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease type (relapsed stage 4 vs primary resistant high-risk neuroblastoma).

Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 and 15-19 and high-dose iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) IV over 30 minutes on days 1 and 15. Patients receive autologous CD 34+ peripheral blood stem cells when \^131I-MIBG dosimetry levels reach an acceptable low on days 25-29.

Total whole-body absorbed dose is measured periodically after the first \^131I-MIBG dose is administered and periodically thereafter.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 67 patients will be accrued for this study.

High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma

International Phase II Studies of I-mIBG in Combination With Topotecan and Peripheral Blood Stem Cell Rescue for (A) Primary Resistant High Risk Neuroblastoma and (B) Relapsed Stage 4 Neuroblastoma

Children's Cancer and Leukaemia Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concurrent Xeloda and Radiotherapy for Bone Metastases	NCT00192777	Solid Tumors Bone Metastases	Xeloda External Beam R...	18 Years -	Rambam Health Care Campus
Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer	NCT00581971	Cancer	celecoxib Carboplatin Paclitaxel Radiation Thera...	19 Years -	University of Alabama at Birmingham
High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma	NCT00389766	Neuroblastoma	iodine I 131 me... topotecan hydro... chemotherapy peripheral bloo... radioisotope th... radionuclide im... radiosensitizat... total-body irra...	1 Year - 17 Years	National Cancer Institute (NCI)

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