Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00079950
First received: March 18, 2004
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.


Condition Intervention Phase
Sarcoma, Soft Tissue
Drug: Pegamotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Enzon Pharmaceuticals, Inc.:

Study Start Date: August 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with measurable disease.
  • Target tumors outside prior radiation field(s).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
  • Adequate renal function
  • Adequate liver function
  • No history of hemorrhagic cystitis or evidence of microscopic hematuria
  • Capable of understanding the protocol requirements and risks and providing written informed consent.
  • Either 0 or 1 prior chemotherapy regimens

Exclusion Criteria:

  • Subject has a diagnosis of gastrointestinal stromal tumors.
  • Concurrent serious medical illness unrelated to tumor within the past 6 months.
  • Known chronic infectious disease, such as AIDS or hepatitis.
  • Positive screening pregnancy test or is breast-feeding.
  • A female or male subject of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this study.
  • Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide field radiation within the previous 4 weeks.
  • History of another active malignancy (except non-melanoma skin cancer and carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for the last 2 years.
  • Known or clinically suspected brain metastases.
  • Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant therapy) for soft tissue sarcoma.
  • Received any investigational drug within the last 30 days.
  • Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy or radiation therapy.
  • Received a prior camptothecin analog (e.g., topotecan, irinotecan).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079950

Locations
United States, California
Century City Hospital
Los Angeles, California, United States, 90067
United States, Pennsylvania
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, United States, 19106
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Senior Director, Regulatory Affairs, Enzon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00079950     History of Changes
Other Study ID Numbers: CAM-9009
Study First Received: March 18, 2004
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:
soft
sarcoma
metastatic

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014