Neoplasms

All Conditions

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

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Analgesics

Aldesleukin

Immunomodulating Agents

Zoledronic Acid

Interleukin-2

Diphosphonates

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

4 mg/m2/dose given iv on day 0 of every 28 day cycle

Dose Level 1: 3 x 10\^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle

Dose Level 2: 6 x 10\^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle

Joseph Pressey, MD

Neuroblastoma (NB) is the most common extracranial solid tumor in children, with an annual incidence of 10.5 per million children less than 15 years of age. NB accounts for 15% of childhood cancer deaths. High risk (HR) patients carry a poor prognosis despite treatment with intensive chemotherapy, surgery and/or radiation, autologous bone marrow transplant, and treatment with cis-retinoic acid. New therapies are desperately needed for such patients. Recently, it has been demonstrated that HR NB patients benefit from anti-GD2 antibody therapy which directs the immune system against NB cells. To further explore means of harnessing the immune system to attack NB, the investigators are studying the combination of zoledronic acid (ZOL) and interleukin-2 (IL-2). ZOL has been demonstrated to have direct anti-neuroblastoma effects in laboratory studies. ZOL also augments the production of tumor killing white blood cells called gamma-delta T cells. When used in combination with IL-2, ZOL is capable of eliciting potent anti-cancer effects in patients, in part, via the expansion of gamma-delta T cells. In this present trial the investigators aim to study the tolerability of the combination of ZOL and IL-2 in pediatric NB patients. Patients will also be monitored radiologically for tumor response to therapy. Correlative biological studies will study the ability of this drug combination to elicit the production of NB killing gamma-delta T cells in children.

Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma

Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma: Assessment of Tolerability and In Vivo Expansion γδ T-Cells

The NCI Common Terminology Criteria for AEs will be used for reporting \& identification of dose limiting toxicities. DLTs will include any grade 3 non-hematologic toxicity not included here: Gr 3 nausea \& vomiting \& diarrhea, Gr 3 fever, Gr 3 skin toxicity that remains stable \& tolerable, or improves with treatment within 24 hrs, Gr 3 neurotoxicity with subjective findings, Gr 4 hematologic toxicity, which improves to at least Gr 2 or baseline pre-therapy values within one week of completing IL2 infusion, Gr 3 performance that returns to 50 or higher before the start of the next therapy cycle.

The ability of gamma-delta T cells derived from patients' peripheral blood to kill NB cells in vitro will be quantified by standard tumor cytotoxicity assays.

Peripheral blood mononuclear cells will be immunophenotyped by standard conjugation of fluorescent monoclonal antibodies in order to quantify and phenotype patient lymphocytes using flow cytometry.

Tumor response and progression will be assessed and documented utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Patients with known or suspected bone marrow metastasis will undergo bilateral bone marrow biopsies at the beginning and end of the first course of therapy. This tissue will be fixed and processed per protocol (Appendix I) and infiltrating lymphocytes per hpf will be documented under standard microscopy.

University of Alabama at Birmingham

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

Capecitabine

Trastuzumab

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Fulvestrant

Aromatase Inhibitors

operation methods: breast-conserving surgery, mastectomy, axillary lymph node dissection, sentinal lymphnodes biopsy; chemotherapy regimens: AC, TC, AC-T/P, TCrb, TAC, capecitabine; ovarian protection:GnRHa; endocrine therapy: Aromatase inhibitor, TAM, Fulvestrant, CDK4/6 inhibitors; target therapy: trastuzumab，patuzumab, Pyrotinib.

operation

Bisphosphonate

Ying Zhong

Xuefei Wang

The elderly patients over 65 years old with breast cancer have concomitant diseases, poor tolerance to conventional treatment, and the specific prognosis of breast cancer is relatively good. Previous studies on breast cancer have almost excluded elderly breast cancer patients, and conventional treatment schemes cannot meet the clinical diagnosis and treatment needs of elderly breast cancer patients. The establishment of a prognosis model for elderly breast cancer patients can provide personalized treatment programs. This is important for prolonging the survival time of patients and improving the quality of life. This project plans to observe the relationship between prognosis and pathological staging, molecular typing, and concomitant diseases of elderly breast cancer patients in combination with immune genes, and establish a prognosis model of elderly breast cancer and verify it. This project is expected to establish a new prognostic model for elderly breast cancer patients, accurately judge the prognosis of patients, and provide a new basis for hierarchical and personalized treatment of elderly breast cancer.

Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients

5-year of breast cancer-specific survival

10-year of breast cancer-specific survival

Peking Union Medical College Hospital

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Osteoporosis

Tooth Loss

Anodontia

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Tooth Diseases

Congenital Abnormalities

Tooth Abnormalities

Stomatognathic System Abnormalities

Denosumab

Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ

Patient with osteoporosis - antiresorptive treatment \> 4 years who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Patient with osteoporosis - antiresorptive treatment \> 4 years with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Cancer patient treated with high dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Cancer patients (breast, prostate or multiple myeloma) treated with high dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Dental surgery in patients treated with antiresorptive medication

Dental implant surgery

Prosthetic treatment and loading of the dental implants

Prosthetic treatment

Sanne Werner Moeller Andersen, DDS

Thomas Kofod, PhD

Thomas Steengaard Kofod, PhD

Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose \> 4 years.

The hypothesis of the present study is that dental implant therapy using submerged healing is feasible and predictable in patients receiving high, adjuvant or low dose AR for more than 4 years, as documented by clinical and radiographic signs of osseointegration after 3-4 months, sufficient implant stability for abutment connection, and implant survival rates comparable to those of healthy individuals after one year of prosthetic loading.

Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery

Defined as presence of the implant at time of final prosthetics

Defined as presence of the implant 1 year after loading of the final prosthetics

Defined as presence of the implant 2 years after loading of the final prosthetics

Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment

Defined as no exposed bone, no fistula, no radiologic sign of MRONJ

Using OHIP-14 questionnaire to evaluate oral health-related quality of life

Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients

Amgen

Institut Straumann AG

Copenhagen University Hospital at Herlev

Oral and Maxillofacial Surgeon

Tamoxifen

Hormones

Goserelin

Anastrozole

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Enzyme Inhibitors

Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)

Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)

tamoxifen

anastrozole

zoledronic acid

3.6 mg goserelin subcutaneously every 28 days

goserelin

Raimund Jakesz, MD

The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors.

A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate).

Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)

DFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from any cause

RFS is defined as time from randomization to first occurrence of a local, regional, or distant recurrence, second primary carcinoma (including contralateral breast cancer), or death from breast cancer

OS is defined as time from randomization to death from any cause

AstraZeneca

Novartis Pharmaceuticals

Austrian Breast & Colorectal Cancer Study Group

All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.

Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid)

anastrozole: 1 mg/d

zoledronic acid: 4 mg q6m

goserelin: 3.6 mg goserelin subcutaneously every 28 days

AZ (Arimidex+Zoledronate)

Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid)

tamoxifen: 20 mg/d

zoledronic acid: 4 mg q6m

goserelin: 3.6 mg goserelin subcutaneously every 28 days

TZ (Tamoxifen+Zoledronate)

Study Drug Arimidex (Anastrozole)

anastrozole: 1 mg/d

goserelin: 3.6 mg goserelin subcutaneously every 28 days

AC (Arimidex Control)

Study Drug Nolvadex (Tamoxifen)

tamoxifen: 20 mg/d

goserelin: 3.6 mg goserelin subcutaneously every 28 days

TC (Tamoxifen Control)

Total

Age, Continuous

Sex: Female, Male

The pathologic T-stage (pT) describes the categories of tumor size: pT1: \<2 cm, pT2: 2 to 5 cm, pT3: \> 5 cm.

pT-stage

The pathologic N-stage (pN) describes the categories of affected lymph nodes: negative: no lymph node affected, positive: at least one lymph node affected.

pN-stage

The histologic grade describes to which extent the cancer cells and their arrangement look look like normal cells. Grade 1 (G1): well-differentiated, cells look more like normal breast tissue; Grade (G2): moderately differentiated; Grade (G3): poorly differentiated; GX: grade cannot be assessed.

Histologic grade

Estrogen receptor status

Progesterone receptor status

Preoperative chemotherapy

Trial Office Director

To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Disease-free Survival (DFS)

To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.

From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Recurrence-free Survival (RFS)

To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.

Comparison of Anastrozole vs Tamoxifen in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.

Intent-to-treat population: All participants assigned to one of the four treatment arms were included in the analysis.

Comparison of Zoledronate vs no Zoledronate in Premenopausal Patients With Non-metastatic Breast Cancer With Respect to Overall Survival (OS)

Overall Study

Alendronate

Placebo

Ting Fan Leung, MBChB, MD

Patrick MP Yuen, MD, FRCPC

Chi Kong Li, MBBS, MD

Christopher WK Lam, PhD

Vincent Lee, MBChB

Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.

The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Zoledronic Acid and Interleukin-2 for Refractory Pediatric Neuroblastoma	NCT01404702	Neuroblastoma	Zoledronic Acid Aldesleukin	2 Years - 21 Years	University of Alabama at Birmingham
Prospective Research for Elderly (≥65 Years Old) Early Breast Cancer Patients	NCT05680194	Breast Cancer F...	operation Bisphosphonate	65 Years - 100 Years	Peking Union Medical College Hospital
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication	NCT04741906	Missing Teeth Implants Cancer Osteoporosis	Dental implant ... Prosthetic trea...	-	Copenhagen University Hospital at Herlev
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid	NCT00295646	Breast Cancer	tamoxifen anastrozole zoledronic acid goserelin	19 Years - 59 Years	Austrian Breast & Colorectal Cancer Study Group
Fosamax for Childhood Cancer Survivors	NCT00391404	Osteoporosis	Alendronate Placebo	15 Years -	Chinese University of Hong Kong
Breast Cancer Women on Aromatase Inhibitors Treatment	NCT03811509	Osteoporosis Osteoporosis Fr... Arthralgia Gene...	bisphosphonate	40 Years - 80 Years	Parc de Salut Mar
Fosamax for Childhood Cancer Survivors	NCT00391404	Osteoporosis	Alendronate Placebo	15 Years -	Chinese University of Hong Kong
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication	NCT04741906	Missing Teeth Implants Cancer Osteoporosis	Dental implant ... Prosthetic trea...	-	Copenhagen University Hospital at Herlev
Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer	NCT00760370	Multiple Myelom... Breast Cancer	Zoledronic Acid	-	Vejle Hospital
Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer	NCT00760370	Multiple Myelom... Breast Cancer	Zoledronic Acid	-	Vejle Hospital
Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancers	NCT01367288	Locally Advance... Ductal Histolog... Without Her 2 O...	Zometa + Neoadj... Neoadjuvant the...	18 Years -	Hospices Civils de Lyon

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