Clinical Trials Logo
  1. Home
  2. Chondrosarcoma
  3. NCT01553539

Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery

Recurrent Osteosarcoma Clinical Trial

Official title:
A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas

Clinical Trial Summary

This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor.

Funding Source - FDA Office of Orphan Drug Products (OOPD)

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive toxicity is observed at the 20 mg dose.

II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients with chemotherapy-refractory sarcomas.

SECONDARY OBJECTIVES:

I. To assess time to progression (TTP) and overall survival (OS) in patients treated with Ang-(1-7).

II. To evaluate accumulation of Ang-(1-7) after 21 days of continuous treatment and quantify changes in plasma levels of angiogenic peptides including placental growth factor (PlGF).

OUTLINE:

Patients receive therapeutic angiotensin-(1-7) subcutaneously (SC) once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01553539
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase Phase 2
Start date October 2009
Completion date January 2013
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06041490 - Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation Phase 2
Not yet recruiting NCT05515068 - Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Completed NCT00093821 - Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors Phase 1
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Completed NCT00091182 - Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment Phase 2
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Completed NCT00004078 - Irinotecan in Treating Children With Refractory Solid Tumors Phase 2
Active, not recruiting NCT04284774 - Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2
Active, not recruiting NCT03213678 - Samotolisib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT04668300 - Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma Phase 2
Completed NCT02470091 - Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma Phase 2
Completed NCT01807052 - Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas N/A
Completed NCT01016015 - Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma Phase 2
Active, not recruiting NCT03698994 - Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Active, not recruiting NCT03213665 - Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial) Phase 2
Not yet recruiting NCT03205644 - VX15/2503 in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04320888 - Selpercatinib for the Treatment of Advanced Solid Tumors, Lymphomas, or Histiocytic Disorders With Activating RET Gene Alterations, a Pediatric MATCH Treatment Trial Phase 2
Completed NCT00030667 - Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood Phase 2
Active, not recruiting NCT02867592 - Cabozantinib-S-Malate in Treating Younger Patients With Recurrent, Refractory, or Newly Diagnosed Sarcomas, Wilms Tumor, or Other Rare Tumors Phase 2