Neoplasms

Musculoskeletal Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Bone Neoplasms

Giant Cell Tumors

Giant Cell Tumor of Bone

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Bone Diseases

Neoplasms, Bone Tissue

Bone Density Conservation Agents

All Drugs and Chemicals

Zoledronic Acid

4 mg, monthly for 3 months followed by a 3-monthly schedule for up to one year after surgery

Zoledronic acid

J R Kroep, MD PhD

P D Dijkstra, MD PhD

A H Taminiau, MD PhD

P C Hogendoorn, MD PhD

H Gelderblom, MD PhD

N A Hamdy, MD PhD

S E Papapoulos, MD PhD

This is a multicenter, randomised phase II trial in patients with high risk GCT.

Primary objective:

* Determine if adjuvant zoledronic acid improves the 2 years recurrence rate of 'high risk' GCT as compared to standard care

Secondary objectives:

* Determine the relapse free survival
* Evaluate the usefulness of bone remodelling markers in diagnosing and monitoring GCT

GCT is a potentially malignant tumour that presents with a locally destructive osteolytic lesion. The high risk GCT are characterized by a high recurrence rate around the 40-45%. Zoledronic acid is a potent inhibitor of osteolysis and is capable of inducing osteoclast and stromal cell apoptosis, which makes it an attractive adjuvant treatment in 'high risk' GCT in order to improve clinical outcomes and reduce the recurrence rate.

Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)

Adjuvant Zoledronic Acid in 'High Risk' Giant Cell Tumour of Bone (GCT) - A Randomized Phase II Study

Leiden University Medical Center

MD PhD

Neoplasms, Germ Cell and Embryonal

Germ Cells Tumors

Antineoplastic Agents

Bevacizumab

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunotoxins

Immunoconjugates

Immunologic Factors

* Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.
* Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.

Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)

Shilpa Gupta

This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP) or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and determined by treating physician to be clinically significant. Patients unable to receive 2nd line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.

Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors

Phase II Study of Brentuximab Vedotin and Bevacizumab in Men With Refractory CD-30 Positive Germ Cell Tumors

Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

In addition to CT scan to assess for disease evaluation, whole body bone scans will be done for patients with known or suspected bone metastases to assess for bone lesions.

Incidence of Progression-free survival - Number of patients who were alive and did not have disease progression

Number of participants who were alive at 2 years (Overall survival)

Safety/ toxicity of brentuximab vedotin, measured by incidence of AEs/SAEs

Masonic Cancer Center, University of Minnesota

Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated. Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days

Brentuximab Vedotin & Bevacizumab

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Shilpa Gupta

Disease Response Rate as Defined by the RECIST 1.1 Criteria, Integrated With Tumor Marker Response.

Number of Participants Experiencing Progression Free Survival

Number of Participants Who Were Alive at 2 Years - Overall Survival

Number of Participants Experiencing Adverse Events (AE) and Severe Adverse Events (SAE)

* Bevacizumab will be administered at a dose of 15 mg/kg IV every 21 days; over 90 minutes during 1st infusion, over 60 minutes as 2nd infusion and over 30 minutes for subsequent infusions if prior infusions well tolerated.
* Brentuximab vedotin will be administered first at 1.8 mg/kg (maximum dose of 180 mg) IV over 30 minutes every 21 days.

Brentuximab Vedotin: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)

Bevacizumab: 15 mg/kg every 21 days

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)	NCT00889590	Giant Cell Tumo... Osteoclastoma	Zoledronic acid	18 Years -	Leiden University Medical Center
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors	NCT02988843	Germ Cell Tumor	Brentuximab Ved... Bevacizumab	18 Years -	Masonic Cancer Center, University of Minnesota
Adjuvant Zoledronic Acid in High Risk Giant Cell Tumour of Bone (GCT)	NCT00889590	Giant Cell Tumo... Osteoclastoma	Zoledronic acid	18 Years -	Leiden University Medical Center
Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors	NCT02988843	Germ Cell Tumor	Brentuximab Ved... Bevacizumab	18 Years -	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for gct

Every month we try and update this database with for gct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gct

Every month we try and update this database with for gct cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gct cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.