Archive for the ‘Osteosarcoma clinical trials’ Category

Radiotherapy for local control of osteosarcoma☆

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Posted 31 Mar 2011 — by James Street
Category Local Recurrence, Lung Metastases, Metastases, Osteosarcoma, Osteosarcoma clinical trials, Proton Beam, Radiation

International Journal of Radiation Oncology * Biology * Physics
* Thomas F. DeLaney, M.D.
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
o Corresponding Author InformationReprint requests to: Thomas F. DeLaney, M.D., Department of Radiation Oncology, Northeast Proton Therapy Center, Massachusetts General Hospital, 30 Fruit St., Boston MA 02114, USA. Tel: (617) 726-7869; Fax: (617) 724-9532;
email address
* , Lily Park, B.A.
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
* , Saveli I. Goldberg, Ph.D.
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
* , Eugen B. Hug, M.D.
Affiliations
o Department of Radiation Oncology, Dartmouth Hitchcock Medical Center, Lebanon, NH, USA
* , Norbert J. Liebsch, M.D., Ph.D.
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
* , John E. Munzenrider, M.D.
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
* , Herman D. Suit (M.D., D.Phil)
Affiliations
o Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

Received 22 December 2003; received in revised form 14 May 2004; accepted 19 May 2004.

Abstract
Purpose
Local control of osteosarcoma in patients for whom a resection with satisfactory margins is not achieved can be difficult. This study evaluated the efficacy of radiotherapy (RT) in this setting.

Methods and materials

We identified 41 patients in our sarcoma database with osteosarcomas that either were not resected or were excised with close or positive margins and who underwent RT with external beam photons and/or protons at our institution between 1980 and 2002. Patient charts were reviewed to assess local control, progression-free survival, metastasis-free survival, and overall survival.

Results

The anatomic sites treated were head/face/skull in 17, extremity in 8, spine in 8, pelvis in 7, and trunk in 1. Of the 41 patients, 27 (65.85%) had undergone gross total tumor resection, 9 (21.95%) subtotal resection, and 5 (12.2%) biopsy only. The radiation dose ranged from 10 to 80 Gy (median 66). Twenty-three patients (56.1%) received a portion of their RT with protons. Chemotherapy was given to 35 patients (85.4%). Of the 41 patients, 27 (65.85%) were treated for localized disease at primary presentation, 10 (24.4%) for local recurrence, and 4 (9.8%) for metastatic disease. The overall local control rate at 5 years was 68% ± 8.3%. The local control rate according to the extent of resection was 78.4% ± 8.6% for gross total resection 77.8% ± 13.9% for subtotal resection, and 40% ± 21.9% for biopsy only (p < 0.01). The overall survival rate according to the extent of resection was 74.45% ± 9.1% for gross total resection, 74.1% ± 16.1% for subtotal resection, and 25% ± 21.65% for biopsy only (p < 0.001). Patients with either gross or subtotal resection had a greater rate of local control, survival, and disease-free survival compared with those who underwent biopsy only at 5 years (77.7% ± 7.5% vs. 40% ± 21% [p <0.001], 73.9% ± 8.1% vs. 25% ± 21.6% [p <0.001], and 51.9% ± 9.1% vs. 25% ± 21.6% [p <0.01], respectively). Overall survival was better in patients treated at primary presentation (78.8% ± 8.6% compared with 54% ± 17.3% for recurrence) p <0.05). No definitive dose–response relationship for local control of tumor was seen, although the local control rate was 71% ± 9% for 32 patients receiving doses ≥55 Gy vs. 53.6% ± 20.1% for 9 patients receiving <55 Gy (p = 0.11). Of 15 patients with tumors >5.3 cm, 9 received doses ≥55 Gy and the local control rate was 80% ± 17.9%, and 6 received doses <55 Gy with a local control rate of only 50% ± 25% at 5 years (p = 0.16). Among patients who underwent gross total resection, the local control rate was 77.5% ± 9.95% in 22 patients with negative margins vs 66.7% ± 27.2% in 3 patients with positive margins (p = 0.54). Two patients had unknown margin status.

Conclusion

RT can help provide local control of osteosarcoma for patients in whom surgical resection with widely, negative margins is not possible. It appears to be more effective in situations in which microscopic or minimal residual disease is being treated.

 

Epeius Biotechnologies’ REXIN-G, A Tumor-Targeted Genetic Medicine For Metastatic Cancer, Gains Phase 3 Product Designation From The U.S. FDA

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Posted 03 Mar 2011 — by James Street
Category genetic, genetic research, genetic research, Local Recurrence, Lung Metastases, Metastases, Molecular Osteosarcoma Studies, Osteosarcoma clinical trials, Targeted Cancer Therapy

01 Mar 2011

Epeius Biotechnologies announced that the U.S. FDA has granted Phase 3 status for the Company’s lead anti-cancer agent, Rexin-G, the first, and so far only, targeted gene delivery system developed to seek out and destroy metastatic cancer. According to Dr. Maria Gordon, Chief Medical Officer of Epeius, “What this means, in terms of clinical development, is that the Rexin-G product, with its advanced GMP manufacturing, bio-processing, and final formulation, meets rigorous FDA standards for obtaining a marketing license in the future; and that Epeius Biotech can now proceed with its strategic, diversified Phase 3 drug development program for pancreatic cancer, osteosarcoma and soft tissue sarcoma.”

In addition to these high-priority programs, Rexin-G has demonstrated significant anti-tumor activity in chemotherapy-resistant breast cancer, hormone-refractory prostate cancer, ovarian cancer, squamous cell carcinoma, and certain hematologic malignancies, such as large B-cell lymphoma.

Rexin-G® was granted accelerated approval for the treatment of all chemotherapy-resistant solid malignancies in the Republic of the Philippines in 2007. In the U.S.A., Rexin-G gained Orphan Drug Designation and market protections from the FDA for pancreatic cancer in 2003, followed by Orphan Drug Status for both osteosarcoma and soft tissue sarcoma in 2008. More recently, Epeius Biotechnologies completed a series of Phase 1 and Phase 2 clinical trials in the U.S., establishing the thresholds for bioactivity and dose-dependent efficacy for Rexin-G against a number of otherwise intractable cancers, as well as the product’s overall safety over extended survival times and a notable lack of either safety issues or dose-limiting toxicities.

With these development-stage accomplishments at hand, Epeius is gearing up to open a series of pivotal studies for both pancreatic cancer and sarcomas in the U.S., while continuing to advance the clinical utility and market development of Rexin-G worldwide. With the completion of the enabling platform development and the clinical validation of its foremost oncology product, Epeius Biotechnologies continues to lead the field of genetic medicine with the development of its product pipeline, which includes Reximmune-C, a tumor-targeted gene delivery system for ‘personalized’ cancer vaccinations, administered to stimulate a long-lasting anti-tumor immunity.

Source: Epeius Biotechnologies Corporation

Article URL: http://www.medicalnewstoday.com/articles/217745.php

Main News Category: Cancer / Oncology

Also Appears In:  Pharma Industry / Biotech Industry,  Clinical Trials / Drug Trials,  Regulatory Affairs / Drug Approvals,

Osteosarcoma Clinical Trial: Inhaled Sargramostim

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Posted 19 Jan 2011 — by James Street
Category Clinical Trials, Osteosarcoma, Osteosarcoma clinical trials

Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma

Official Title: Phase II Study of Aerosolized Sargramostim (GM-CSF) in Patients With First Pulmonary Recurrence of Osteosarcoma
Purpose

RATIONALE: Inhaling aerosolized sargramostim before and after surgery may interfere with the growth of tumor cells and shrink the tumor so that it can be removed during surgery. Sargramostim may then kill any tumor cells remaining after surgery. This may be an effective treatment for osteosarcoma that has spread to the lung.

PURPOSE: This phase II trial is studying how well inhaled sargramostim works in treating patients who are undergoing surgery for the first recurrence of osteosarcoma that has spread to the lung.

OBJECTIVES:

* Assess the histological findings from patients with first pulmonary recurrence of osteosarcoma who undergo resection of pulmonary metastases after treatment with 2 courses of aerosolized sargramostim (GM-CSF).
* Determine the event-free survival of patients treated with this drug.
* Determine the effect of specific thoracic surgical management on outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to the extent of pulmonary recurrence (unilateral or bilateral).

* Initial inhalation therapy: Patients receive inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every 14 days for 2 courses.
* Thoracotomy: Patients undergo thoracotomy on day 22.
* Post-thoracotomy inhalation therapy: Beginning on day 29, patients resume inhalation therapy as above for up to 12 additional courses.
* Unilateral thoracotomy: Patients undergo unilateral thoracotomy on day 1.
* Initial inhalation therapy: Patients receive inhaled GM-CSF twice daily on days 7-14. Treatment repeats every 14 days for 2 courses.
* Contralateral thoracotomy: Patients undergo contralateral thoracotomy on day 29.
* Post-thoracotomy inhalation therapy: Beginning on day 36, patients resume inhalation therapy as above for up to 12 additional courses.

Treatment in both groups continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Eligibility

Ages Eligible for Study: up to 39 Years
Disease Characteristics:

* Histologically confirmed osteosarcoma at primary diagnosis
* Lesions detected in at least 1 lung that are consistent with metastatic disease and approachable with thoracotomy
* No prior recurrence of osteosarcoma
* No other sites of metastases
* Resectable pulmonary nodule(s), defined as nodule(s) that are removable without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels)
* Prior thoracotomy allowed in patients with imaging consistent with metastatic involvement in both lungs provided the lung on which the thoracotomy was performed is disease-free
* No pleural effusion

Patient Characteristics:

* Age: 39 and under
* Pulmonary:
o No evidence of dyspnea at rest
o No exercise intolerance
o Pulse oximetry at least 94%
o Baseline FEV_1 at least 75% of normal
* Other:
o Willing and able to perform inhalation therapy
o No medical contraindication to surgical excision

Prior Concurrent Therapy:

* Biologic therapy:
o No other concurrent immunotherapy
o No other concurrent immunomodulating agents
* Chemotherapy: No concurrent anticancer chemotherapy
* Endocrine therapy: No concurrent steroids by any route
* Surgery:
o See Disease Characteristics
o No concurrent thoracoscopy or video-assisted thoracic surgery
* Other:
o No more than 1 prior treatment regimen for osteosarcoma
o No concurrent participation in another COG therapeutic study

Location and Contact Information
Arizona

Phoenix Children’s Hospital, Phoenix, Arizona, 85016-7710, United States; Recruiting
Jessica L. Boklan 602-546-0920
Arkansas

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States; Recruiting
David Becton 501-364-5650
California

Southern California Permanente Medical Group, Downey, California, 90242-2814, United States; Recruiting
Robert Cooper 323-783-5307

Stanford Cancer Center at Stanford University Medical Center, Stanford, California, 94305, United States; Recruiting
Clinical Trials Office – Stanford Cancer Center at Stanford Un 650-498-7061. E-mail
District of Columbia

Children’s National Medical Center, Washington, District of Columbia, 20010-2970, United States; Recruiting
Clinical Trials Office – Children’s National Medical Center 202-884-2549
Florida

Baptist-South Miami Regional Cancer Program, Miami, Florida, 33176, United States; Recruiting
Doured Daghistani 305-274-1662

Kaplan Cancer Center at St. Mary’s Medical Center, West Palm Beach, Florida, 33407, United States; Recruiting
Narayana Gowda 561-844-6363

Lee Cancer Care of Lee Memorial Health System, Fort Myers, Florida, 33901, United States; Recruiting
Clinical Trials Office for Lee Cancer Care of Lee Memorial Hea 877-680-0008

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, 32504, United States; Recruiting
CTO contact for Sacred Heart Cancer Center at Sacred Heart Hos 850-416-4611
Georgia

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31403-3089, United States; Recruiting
Clinical Trials Office – Curtis & Elizabeth Anderson Cancer In 912-350-8568

Emory University Hospital – Atlanta, Atlanta, Georgia, 30322, United States; Recruiting
Howard M. Katzenstein 404-785-0853
Idaho

St. Luke’s Mountain States Tumor Institute – Boise, Boise, Idaho, 83712-6297, United States; Recruiting
J. M. Johnston 208-381-2782
Illinois

Children’s Memorial Hospital – Chicago, Chicago, Illinois, 60614, United States; Recruiting
Susan Cohn 773-880-4562

Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9620, United States; Recruiting
Clinical Trials Office – Southern Illinois University School o 217-545-7929
Indiana

St. Vincent Indianapolis Hospital, Indianapolis, Indiana, 46260, United States; Recruiting
Clinical Trials Office – St. Vincent Indianapolis Hospital 317-338-2194
Maryland

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Clinical Trials Office 410-955-8804. E-mail
Michigan

Hurley Medical Center, Flint, Michigan, 48503, United States; Recruiting
Clinical Trials Office – Hurley Medical Center 810-762-8057

Spectrum Health Cancer Care – Butterworth Campus, Grand Rapids, Michigan, 49503-2560, United States; Recruiting
David R. Freyer 616-391-2086

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, 48236, United States; Recruiting
Clincial Trials Office – Van Elslander Cancer Center 313-343-3166
Minnesota

Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
Clinical Trials Office 507-538-7623
New Jersey

Cancer Institute of New Jersey at UMDNJ – Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Clinical Trials Office – Cancer Institute of New Jersey at UMD 732-235-8675
New York

SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Clinical Trials Office – SUNY Upstate Medical University Hospi 315-464-5476
Ohio

Children’s Medical Center – Dayton, Dayton, Ohio, 45404-1815, United States; Recruiting
Emmett Broxson 937-641-3111

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195-5217, United States; Recruiting
Joanne M. Hilden 216-444-8407
Oklahoma

Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
William Meyer 405-271-5311
Oregon

Institute of Oncology at Vilnius University, Portland, Oregon, 97227, United States; Recruiting
Janice F. Olson 503-413-2560
Pennsylvania

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033-0850, United States; Recruiting
Clinical Trials Office 717-531-3779. E-mail
South Carolina

Greenville Hospital System Cancer Center, Greenville, South Carolina, 29605, United States; Recruiting
Clinical Trials Office 864-241-6251

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, 29203, United States; Recruiting
Clinical Trials Office – Palmetto Health South Carolina Cancer 803-434-3680
Tennessee

East Tennessee Children’s Hospital, Knoxville, Tennessee, 37916, United States; Recruiting
Ray C. Pais 865-541-8266
Texas

CCOP – Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Dick Y. Suh 254-724-9852

Covenant Children’s Hospital, Lubbock, Texas, 79410, United States; Recruiting
John Iacuone 806-725-4840
Utah

Primary Children’s Medical Center, Salt Lake City, Utah, 84113-1100, United States; Recruiting
Phillip E. Barnette 801-588-2680
Washington

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, 99220-2555, United States; Recruiting
Judy Felgenhauer 509-474-2777
Wisconsin

Marshfield Clinic – Marshfield Center, Marshfield, Wisconsin, 54449, United States; Recruiting
Clinical Trials Office – Marshfield Clinic 800-782-1581 ext. 94457

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, 54307-3508, United States; Recruiting
Clinical Trials Office – St. Vincent Hospital Regional Cancer 920-433-8889

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6164, United States; Recruiting
Clinical Trials Office for University of Wisconsin Comprehensi 608-262-5223
Canada, Nova Scotia

IWK Health Centre, Halifax, Nova Scotia, B3K 6R8, Canada; Recruiting
Margaret C. Yhap 902-470-8778
Canada, Ontario

McMaster Children’s Hospital at Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada; Recruiting
Carol A. Portwine 905-521-2100×73428
Canada, Quebec

Centre Hospitalier Universitaire de Quebec, Ste Foy, Quebec, G1V 4G2, Canada; Recruiting
Yvan Samson 418-656-4141×47191

McGill Cancer Centre at McGill University, Montreal, Quebec, H3H 1P3, Canada; Recruiting
Sharon Abish 514-412-4400×22219
Study chairs or principal investigators

Carola A.S. Arndt, MD, Study Chair, Mayo Clinic